The Standards, Tests and Registrations Behind Every Product

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk.

When a buyer needs it: US, European Market

ISO 13485 is a quality management system standard that allows an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

When a buyer needs it: ISO 13485 supports medical device manufacturers by providing a framework necessary to demonstrate compliance to regulatory requirements in the following areas: - Management responsibility - Product realization - Resource management - Measurement, analysis and improvement

ISO 14001 defines criteria for an environmental management system.

When a buyer needs it: ISO 14001 is required in 171 countries, such as China, Japan, Spain, Italy, United Kingdom, Republic of Korea, Romania, Germany, USA, Czech Republic etc.

ISO 14971 Medical devices , Application of risk management to medical devices is an ISO standard for the application of risk management to medical devices.

When a buyer needs it: The risk management process presented in ISO 14971 includes: - Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk. - Estimating the potential occurrence of such risks, and evaluating the extent of the consequences. - Developing and implementing active safeguards within the device or the production process to control risks. - Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process. - Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design. A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional safety and usability with minimal impact to the product development schedule. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits can result in faster time to market, and greater competitive advantages.

ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories.

When a buyer needs it: In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.

ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

When a buyer needs it: ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

ISO 9001 is an International Standard that gives requirements for an organization’s quality management system.

When a buyer needs it: The objective of ISO 9001 is to provide a set of requirements that, if effectively implemented, will give you confidence that your supplier can consistently provide products and services that: • Meet your needs and expectations • Comply with applicable regulations

Sterilization of health-care products , Ethylene oxide , Requirements for the development, validation and routine control of a sterilization process for medical devices.

When a buyer needs it: Sterilization

BSCI is an initiative of the Foreign Trade Association (FTA), the leading business association of European and international commerce that brings together over 1,500 retailers, importers, brands and national associations to improve the political and legal framework for trade in a sustainable way. BSCI support more than 1,500 FTA member companies to integrate social compliance at the heart of their global supply chains.

The GMP Certificate is a document issued by Anvisa attesting that a particular establishment complies with Good Manufacturing Practices.

The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.

The China Food and Drug Administration (CFDA) (Chinese: 国家食品药品监督管理总局) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency. The CFDA replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States, streamlining regulation processes for food and drug safety. The China Food and Drug Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

GACC will inspect and release the exports according to the list of manufacturers with foreign standard certification or registration provided by MOFCOM, which is known as the “China Medical Device Exportation Whitelist”.

The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.

The Environmental Protection Agency (EPA) was established in December 1970 by the executive order of President Richard Nixon. It is an agency of the United States federal government whose mission is to protect human and environmental health. Headquartered in Washington, D.C., the EPA is responsible for creating standards and laws promoting the health of individuals and the environment.

All medical devices must be registered with the FDA. Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared” or “Approved,” and they cannot use the FDA logo in marketing or labeling the device.

The Forest Stewardship Council (FSC) is an international non-profit, multistakeholder organization established in 1993 that promotes responsible management of the world's forests. It is an example of a market-based certification program used as a transnational environmental policy.

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.

KFDA means Korean Food and Drug Administration. The competent regulatory authority in Korea that is responsible for granting Marketing Authorization for a regulated pharmaceutical in Korea.

A material safety data sheet is a technical document which provides detailed and comprehensive information on a controlled product related to:  health effects of exposure to the product  hazard evaluation related to the product’s handling, storage or use  measure to protect workers at risk of exposure  emergency procedures.

The US Center for Disease Control (CDC) National Institute for Occupational Safety and Health (NIOSH) regulates respirators (N95 masks) for occupational health. NIOSH maintains an extensive list of approved N95 respirators. These NIOSH rated respirators are intended for industrial use, but are appropriate for healthcare use under the emergency circumstances brought on by the COVID-19 pandemic, hence these respirators will not be found on the FDA Establishment Registration & Device Listing database.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health(link is external), and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The US Food and Drug Administration (FDA) requires manufacturers of certain classes of products to submit a technical dossier to demonstrate that the device is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA reviews the 510(k) submission and "clears" the specific device. Certain classes of medical devices require such clearance before they can be legally distributed in the United States.

During the COVID-19 crisis, the FDA issued Emergency Use Authorizations (EUAs) that waived certain regulatory requirements and specifically authorized the importation and distribution of specific items listed in the EUA for the uses described in the EUA, so long as the importation, distribution or use of such items fell within the scope of authorization in the EUA. On June 30, 2021 the FDA removed a number of products from the EUA list, including KN95 masks as well as decontamination and bioburden reduction systems to disinfect disposable respirators. This action was taken in response to an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. While the FDA has revoked its EUA for KN95 masks, it does not mean that these respirators are not adequate for consumer use, only that they are no longer appropriate for healthcare workers given the abundant supply of N95 respirators.

Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method

When a buyer needs it: USFDA

Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method

When a buyer needs it: USFDA

Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method

When a buyer needs it: USFDA

Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes

When a buyer needs it: USFDA

Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method

When a buyer needs it: USFDA

Official Method 966.04, Sporicidal Activity of Disinfectants Method I

When a buyer needs it: USFDA

Official Method 965.12 Tuberculocidal Activity of Disinfectants

When a buyer needs it: USFDA

Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method

When a buyer needs it: USFDA

Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method

When a buyer needs it: USFDA

Chemical sterilization and high-level disinfection in health care facilities

This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring.

When a buyer needs it: USFDA

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. By specifying a consistent basis for testing and labeling protective apparel and drapes and providing a common understanding of barrier properties (e.g. efficacy against liquid or liquid-borne microorganism penetration) based on this new classification system, the standard is intended to ultimately assist en-users in determining the type(s) of protective product most appropriate for a particular task of situation. Preference Test Methods: AATCC 42 AATCC 127 AATCC 42: AATCC 127 ASTM F1671 ASTM F1670

When a buyer needs it: US market

Standard test method for peel adhesion of pressure sensitive tape

When a buyer needs it: USFDA

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

When a buyer needs it: USFDA

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

When a buyer needs it: USFDA

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

When a buyer needs it: USFDA

This standard is issued under the fixed designation F2100; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last re-approval. A superscript epsilon indicates an editorial change since the last revision or preapproval. Reference Test Methods: ASTM F2101 - 19. EN 14683:2019+AC:2019. ASTM F2299 / F2299M - 03(2017). ASTM F1862 / F1862M - 17. 16 CFR Part 1610.

When a buyer needs it: US and Canada Market

Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact

When a buyer needs it: US FDA

This European Standard specifies requirements and test methods for reusable and limited use protective clothing providing protection against infective agents. Clothing worn by surgical teams or drapes laid on patients to prevent cross-contamination during surgical interventions are not covered by the scope of this standard. Biological hazards, Re-usable, Performance testing, Infective materials, Health and safety requirements, Hospital equipment, Protective clothing, Health and welfare facilities, Performance, Safety measures.

When a buyer needs it: European Country

Protective clothing against chemicals. Test methods and performance classification of chemical protective clothing materials, seams, joins and assemblages.

When a buyer needs it: European Country

Personal eye-equipment. Faceshields and visors for use with firefighters and high performance industrial safety helmets used by firefighters, ambulance and emergency services. This standard applies to visors designed specifically to be used with firefighters , ambulance and emergency service helmets conforming to EN 443 or prEN 14052. They are intended to provide protection against the various hazards expected to be encountered in firefighting, ambulance and emergency service duties, except respiratory, smoke, and gas / vapour hazards

When a buyer needs it: European Country

Protective clothing against liquid chemicals. Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]). Grades (quality), Chemical-resistant materials, Protective suits, Tensile strength, Water tightness tests, Permeability, Instructions for use, Occupational safety, Penetration tests, Abrasion testing, Marking, Liquids, Performance, Protective clothing, Seams, Splitting tests.

When a buyer needs it: European Country

BS EN 16523-1:2015 (replaces BS EN 374-3:2003) Determination of material resistance to permeation by chemicals.

When a buyer needs it: European Country

EN 166:2001 is the European standard covering the requirements for protective eyewear. EN 166 specifies the minimum requirements for a range of performance tests. This standard contains a set of requirements referred to as ‘basic requirements’, which may be regarded as mandatory.

When a buyer needs it: European Country

This European Standard specifies functional requirements for various types of personal eye-protectors and incorporates general considerations such as designation; classification; basic requirements applicable to all eye-protectors; various particular and optional requirements; allocation of requirements, testing and application; marking; information for users.

When a buyer needs it: European Country

IF NO BS EN374-1:2016 or BS EN 374-2:2014 ASTM D6978-05 OR equivalent technical solutions IS REQUIRED

When a buyer needs it: European Country

IF NO BS EN374-1:2016 or BS EN 374-2:2014 ASTM D6978-05 OR equivalent technical solutions IS REQUIRED

When a buyer needs it: European Country

This part of this standard specifies requirements and give the test method for medical gloves for single use in order to determine freedom from holes.

When a buyer needs it: This European Standard exists in three official version (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Medical gloves for single use. Requirements and testing for physical properties. The gloves are tested to determine dimension (length and palm width) and physical strength (force at break) Examination Gloves Requirement:>=6.0 Newtons or >=3.6 Newtons (for all gloves made from thermoplastic materials (e.g. polyvinylchloride, polyethylene)Surgical Gloves Requirement: >=9.0 Newtons

When a buyer needs it: European Market

This part of this standard specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

When a buyer needs it: European Country

Medical gloves for single use. Requirements and testing for biological evaluation. The gloves are tested to determine the presence of potentially hazardous material that could affect the wearer. The manufacturer shall disclose, upon request, a list of chemical ingredients either added or already known to be present that will cause adverse health effects. Powder-free gloves only: Removable Surface Powder: <=2mg/glove. (N.B. If the powder level is above this level, it is considered to be a powdered glove). Labelling: shall include a prominent indication of whether the glove is powdered or powder-free. Surgical/Sterile Gloves only: Endotoxin: <20EU (Endotoxin units)/pair of gloves.Natural Rubber Latex Gloves only: Examination and Surgical Gloves, Total extractable protein - Result indicated in µg per gram.

When a buyer needs it: European Market

Medical gloves for single use. Requirements and testing for service life determination. The gloves are tested to determine the shelf life that can be applied. This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time.

When a buyer needs it: European Country

IF NO BS EN 556-1:2000 ASTM D3577-19 OR equivalent technical solutions IS REQUIRED

When a buyer needs it: European Market

Biological evaluation of medical devices. Evaluation and testing within a risk management process，Medical technology, Compatibility, Cytotoxicity tests, Contaminants, Medical equipment, Bioassay, Implants (surgical), Biological analysis and testing, Dental materials, Biological hazards, Medical instruments, Clinical investigation instruments, Dental equipment.

When a buyer needs it: European Country

Protective clothing for use against solid particulates. Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing) Particulate materials, Occupational safety, Chemical-resistant materials, Performance, Leak tests, Aerosols, Dust, Protective suits, Solids, Protective clothing This part of ISO 13982 specifies the minimum requirements for chemical protective clothing resistant to penetration by airborne solid particles (type 5). These garments are full-body protective clothing, i.e. covering trunk, arms and legs, such as one-piece coveralls or two piece suits, with or without hood or visors, with or without foot protection. Requirement for component parts, such as hoods, gloves, boots, visors or resiratory protective equipment might be specified in other International and European Standards.

When a buyer needs it: European Country

Protective gloves. General requirements and test methods. This document is a reference standard to be referred to as appropriate by the specific standards relevant or applicable to protective gloves. This document specifies the general requirements and relevant test procedures for glove design and construction, innocuousness, comfort and efficiency, as well as the marking and information supplied by the manufacturer applicable to all protective gloves. It can also apply to arm protectors and gloves permanently incorporated in containment enclosures. Gloves and hand protectors such as mittens, pot holders and arm protection are covered by this document. This document does not address the protective properties of gloves and therefore is not used alone but only in combination with the appropriate specific standard(s). A non-exhaustive list of these standards is given in the Bibliography. Reference Test Methods: ISO 14362-1 ISO/TS 16190 ISO 17234-1 ISO 20344:2011 EN 1811+A1:2015

When a buyer needs it: European Country

Protective gloves against dangerous chemicals and micro-organisms. Determination of resistance to degradation by chemicals.

When a buyer needs it: European Country

Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for micro-organisms risks.

When a buyer needs it: European Country

Clothing for protection against contact with blood and body fluids , Determination of resistance of protective clothing materials to penetration by blood-borne pathogens

When a buyer needs it: European Country

Protective clothing for use against liquid chemical spray and splashes. Performance requirements for light liquid spray providing protection to the full body (type 6 clothing).

When a buyer needs it: European Country

This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating rooms and other medical settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. This standard is intended to help facilitate the choice of surgical face masks in the European Market by standardizing the information and performance data required for the masks. Reference Test Method: EN ISO 10993-1:2009 ISO 22609:2004 EN ISO 11737-1:2018 EN ISO 10993 series EN ISO 139 EN 149

When a buyer needs it: European Market

This European Standard was approved by CEN on 8 March 2001 and includes Corrigendum 1 issued by CEN on 24 July 2002 and Amendment 1 approved by CEN on 26 March 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. This European Standard specifies minimum requirements for filtering half masks as respiratory protective devices to protect against particles except for escape purposes. Laboratory and practical performance tests are included for the assessment of compliance with the requirements. Reference Test Methods: EN 13274-7 EN 143

When a buyer needs it: European Market

Textiles , Standard atmospheres for conditioning and testing. The tolerances for temperature and relative humidity given in ISO 139:1973 were the tolerances for the temperature and relative humidity measured in the laboratory, and without any consideration for the uncertainty of measurement of the measuring devices being used. With the increased understanding since 1973 and the existence now of standards covering these issues (e.g. ISO 14253-1), it is now necessary to allow for the uncertainty of measurement when setting appropriate tolerances. This second edition of ISO 139 includes the allowance for uncertainty of measurement in the overall tolerances for temperature and relative humidity. This means that although the tolerances for temperature and relative humidity appear more lenient than in ISO 139:1973, in practice, the laboratory must still be controlled (measured temperature and humidity) to essentially the same level as stated in ISO 139:1973.

When a buyer needs it: European Country

This document focuses on Essential Requirements arising from the Medical Device Directive 93/42/EEC, which are applicable to surgical drapes and gowns. The requirements and guidance in this document are expected to be of help to manufacturers and users when designing, processing, assessing and selecting products. It is the intention of this document to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout their useful life. Surgical gowns are used to minimize the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. Hereby, surgical gowns contribute to the clinical condition and the safety of patients as well as to the safety and health of users following up essential requirement 1 of Directive 93/42/EEC on Medical Devices. This document addresses the same level of protection for patients and users (i.e. the surgical team) by not differentiating the performance requirements for surgical gowns respectively. However, this document does not formally address any basic health and safety requirements of the Directive 89/686/EEC or Regulation (EU) 2016/425 on Personal Protective Equipment and does not provide specific guidance for surgical gowns intended by the manufacturer for dual use as medical device and personal protective equipment. Reference Test Methods: EN ISO11810 ISO 811:2018 EN 29073-3:1992 ISO 139:2005 + Amd.1:2011 EN ISO 9073-10:2004 EN ISO 10993-1:2009 EN ISO 11737-1:2018 EN ISO 13938-1:1999 EN ISO 22610:2006

When a buyer needs it: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

When a buyer needs it: Worldwide

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

When a buyer needs it: USFDA

Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer

When a buyer needs it: USFDA

ISO 20345:2011 specifies basic and additional (optional) requirements for safety footwear used for general purpose. It includes, for example, mechanical risks, slip resistance, thermal risks, ergonomic behavior. Special risks are covered by complementary job-related standards, e.g. footwear for firefighters, electrical insulating footwear, footwear protecting against chain saw injuries, chemicals, molten metal splash, and protection for motorcycle riders. Reference Test Methods: EN ISO 13287 ISO 20344:2011 EN 12568:2010

When a buyer needs it: European Country

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

When a buyer needs it: USFDA

Procedures for testing and certifying air-purifying and particulate respirators changed under a final regulation published June 8, 1995 by the National Institute for Occupational Safety and Health (NIOSH). This new standard, called 42 CFR part 84, replaces MSHA regulation designated 30 CFR part 11 which is based upon testing methods and filtration theory that is more than 20 years old. This action by NIOSH is the first in a series of modules that will incrementally revise current approval requirements for all respirators. Reference Test Method: 30 CFR 11

When a buyer needs it: US market

The purpose of the Standard is for the issuing of guaranties in accordance with the Flammable Fabrics Act (FFA). The Standard establishes flammability requirements that all clothing textiles, as defined in §1610.2, must meet before sale or introduction into commerce. The Standard provides a method for testing (§1610.6) and establishes three classes of flammability performance of textiles and textile products used for clothing (§1610.4), thereby restricting the use of any dangerously flammable clothing textiles (those designated Class 3). The test procedure requires that a 16 mm (5 /8 in) flame impinge on a specimen mounted at a 45 degree angle for 1 second. The specimen is allowed to burn its full length or until the stop thread is broken, a distance of 127 mm (5 in). The results of several specimens are averaged and a Class designation is made based on the flammability performance and surface characteristics of the sample.

Occupational Exposure to Blood-borne Pathogens: Final Rule

This attribute-only standard assigns sampling plans based on user assigned RQL level and the lot size (N)

Sampling Procedures and Tables for Inspection by Attributes is an acceptance sampling system to be used with switching rules on a continuing stream of lots for Acceptance Quality Limit (AQL) specified.

Sampling plans and procedures for inspection by variables indexed by an AQL level.

ASTM D5712, 2015 Edition, July 1, 2015 - Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method This test method covers an analytical test for determining the amount of total aqueous extractable protein associated with NR, latex, and elastomeric products. Water soluble proteins are extracted in a buffer solution and then precipitated to concentrate them and also to separate them from water soluble substances that may interfere with the determination. The extracted protein is redissolved and quantified colorimetrically by the modified Lowry method using a protein standard. For the purpose of this test method, the range of protein measurement will be based on the limit of detection and quantitation and recorded in micrograms per dm2 test specimen. The test method is designed to be accurate and compatible with the industrial environment. Steps are included in this test method to minimize the effects of interfering substances. It is recognized that other methods for the analysis of leachable proteins exist and these may be used for routine quality control purposes provided they have been validated and a correlation established against the reference method specified by this test method. This test method has not been validated for use with lubricated products such as condoms. Condoms with different lubricants as typically marketed, have not been tested in an ASTM ILS to determine if, and if so to what degree, the lubricant interferes with the assay. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM D6499, 2018 Edition, August 1, 2018 - Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products This test method covers an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other product extracts which have been collected in order to measure the HNR levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established. For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

ASTM D7427, 2016 Edition, June 1, 2016 - Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex This test method covers an immunological method known as an immunoenzymetric assay to quantify the amount of 4 principal Hevea brasiliensis [Hev b] allergenic proteins [Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02] in Hevea natural rubber and its products2 derived from latex using monoclonal antibodies specific for epitopes on these proteins. Since these assays quantify the levels of only 4 of the known 14 officially acknowledged allergens potentially present in Hevea natural rubber latex containing products, the sum of the four allergen levels shall be viewed as an indicator of the allergen burden and not as a measure of the total allergen content that can be released from the product. For the purpose of this test method, the range of allergenic protein will be measured in terms of nanogram to microgram quantities per gram or unit surface area of a Hevea natural rubber containing product. The test method is not designed to evaluate the potential of Hevea natural rubber containing materials to induce or elicit Type I (IgE-mediated) hypersensitivity reactions. This test method should be used under controlled laboratory conditions to detect and quantify the level of 4 allergenic proteins found in Hevea natural rubber containing products. It should not be used to describe, appraise or assess the hazard or risk of these Hevea natural rubber containing materials or products under actual in use conditions. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

The machines with their pendulum-type hammers have been “standardized” in that they must comply with certain requirements, including a fixed height of hammer fall that results in a substantially fixed velocity of the hammer at the moment of impact. However, hammers of different initial energies (produced by varying their effective weights) are recommended for use with specimens of different impact resistance. Moreover, manufacturers of the equipment are permitted to use different lengths and constructions of pendulums, with possible differences in pendulum rigidity resulting. (See Section 5.) Be aware that other differences in machine design may exist. The specimens are “standardized” in that they are required to have one fixed length, one fixed depth, and one particular design of milled notch. The width of the specimens is permitted to vary between limits.

This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance.

This standard defines the specialized terms used in standards developed by Committee F23 on Protective Clothing.

This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.

This test method measures the initial filtration efficiency of materials used in medical face masks by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.

This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH). Spectacle frames and sunglasses are excluded from the scope of this European Standard.

This European Standard specifies the performance classification and test methods for chemical protective clothing material and seams, joins and assemblages. This is a reference standard to which other chemical protective clothing performance standards may refer in whole or in part. NOTE Whilst these performance levels are intended to relate to the usage to which the chemical protective clothing is to be put, it is essential that the user (specifier) and the chemical protective clothing manufacturer or supplier liase to establish the correct performance level for the intended task. For this purpose a risk analysis could be useful.

Application of a force longitudinally to a test piece of a specified length and width at a constant rate of extension. Determination of values for breaking strength and elongation from the recorded force-elongation curve. In order to meet the specific needs of nonwovens, alternative requirements to those listed in ISO 5081 are established in this part of ISO 9073. These are: a) a different sampling procedure; b) a constant rate of extension (100 mm/min).

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

This standard describes a hydraulic method for the determination of bursting strength and bursting distension of textile fabrics. In this part, a hydraulic pressure is applied using a constant rate of pumping device. The method is applicable to knitted, woven, non-woven and laminated fabrics. It may be suitable for fabrics produced by other techniques. The test is suitable for test specimens in the conditioned or wet state. From the available data, there appears to be no significant difference in the bursting strength results achieved using hydraulic or pneumatic burst testers, for pressures up to 800 kPa. This pressure range covers the majority of performance levels expected of general apparel. For specialty textiles requiring high bursting pressures, the hydraulic apparatus is more suitable.

ISO 17491-4:2008 specifies methods for determining the resistance of chemical protective clothing to penetration by sprays of liquid chemicals at two different levels of intensity: Method A: low-level spray test. This is applicable to clothing that covers the full body surface and which is intended to be worn when there is a potential risk of exposure to small quantities of spray or accidental low volume splashes of a liquid chemical. Method B: high level spray test This is applicable to clothing with spray-tight connections between different parts of the clothing and, if applicable, between the clothing and other items of personal protective equipment, which covers the full body surface and which is intended to be worn when there is a risk of exposure to sprayed particles of liquid.

ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.

ISO 22610:2006 specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

There are numerous examples of situations where bacteria may migrate through a barrier material in the dry state carried by organic or inorganic particles. The dry penetration of bacteria-carrying skin scales through an operating gown or a clean air suit is one example. Penetration through a packaging material during storage is another. This document EN ISO 22612 describes a test method, with the associated equipment, that may be used to determine a material's resistance to dry penetration of bacteria on particles in the size range most typical for human skin scales

ISO 811:2018 specifies a hydrostatic pressure method for determining the resistance of fabrics to penetration by water. The method is applicable to all types of fabrics which are intended to be water resistant whether or not they have been given a water-resistant or water-repellent finish.

ISO 9073-10:2003 specifies a test method for measuring the linting of nonwovens in the dry state. It can also be applied to other textile materials.

ISO 13982-2:2004 specifies a test method to determine the barrier efficiency of chemical protective clothing against aerosols of dry, fine dusts.

ISO 22609:2004 describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood. ISO 22609:2004 primarily addresses the performance of materials or certain material constructions used in medical face masks. The test method does not address the performance of the medical face mask's design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). ISO 22609:2004 does not evaluate the performance of medical face masks as a protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.

This part of ISO 2859 specifies an acceptance sampling system for inspection by attributes. It is indexed in terms of the acceptance quality limit (AQL). Its purpose is to induce a supplier through the economic and psychological pressure of lot non-acceptance to maintain a process average at least as good as the specified acceptance quality limit, while at the same time providing an upper limit for the risk to the consumer of accepting the occasional poor lot. Sampling schemes designated in this part of ISO 2859 are applicable, but not limited, to inspection of - end items, - components and raw materials, - operations, - materials in process, - supplies in storage, - maintenance operations, - data or records, and - administrative procedures.

3-6 layer SMS nonwoven provides AAMI level 2 fluid barrier

4-6 layer SMS non-woven material provide AAMI level 3 fluid barrier

SMS material laminated with PE provides AAMI level 4 fluid barrier

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