Everything you need to know about product standards.
A standard is a document, established by consensus and approved by a recognized body, that provides rules, guidelines or characteristics for a product for common and repeated use.
Standards are common in our lives. Every time you look at your watch you’re checking standard time. When you buy a light bulb, you don’t need to worry that it will fit the lamp base, because there’s a standard. When you need a flashlight battery, you don’t have to specify the length, diameter, or voltage – you ask for a C, or D, or AA cell.
What does this mean for purchasers of safety equipment?
Suppose every time you want a hard hat, you have to give your supplier specifications like these:
- A 3.6-kg impactor dropped on the helmet at a velocity of 5.5 m/sec will not transmit a force greater than 4450 Newtons
- A 1-kg impactor with a 60-deg steel tip, dropped at 7.0 m/sec, will not penetrate to the headform
- The helmet’s material cannot burn more than 5 sec after you hold an 800 to 900 deg flame to it for 5 sec.
- The helmet will withstand 20,000 Vrms, AC, at 60 Hz for 3 minutes with no more than 9 mA leakage.
In fact, you do. This is a summary of the common specifications for industrial head protection for use where there may be an electrical hazard. But all you and your supplier need to know is that the helmet conforms to ANSI Z89.1-2009, class E.
Standards are the:
- Shorthand of commerce. They are a common language for the marketplace.
- Standards establish compatibility of components and systems, and make it possible to interchange products from different manufacturers safely and effectively.
- Standards establish a level of performance for a product, system or process. For PPE, this is the protection the product is designed to provide.
- Standards provide a method for verifying that a product is suitable for its intended purpose.
- Standards serve the public good, by establishing levels of safety, health, and environmental protection. Standards are commonly used as the basis for government regulation.
Standards are written by manufacturers and users, government officials, experts, academics, consultants – anyone with knowledge of the product, process or service, an understanding of how to establish common performance characteristics and guidelines, and a willingness to devote time and energy to the process.
There are three broad categories of standards:
- Government standards are generally developed through a formal rulemaking process. Even a government agency’s decision to use voluntary standards must go through notice-and-comment rulemaking. When issued as final rules, they are the law of the land.
- Company standards are specifications that are developed in-house and made available widely. A good example is the PC. IBM’s decision to let other computer makers see and copy the PC’s architecture helped establish its dominance.
- The most common type of standard is the voluntary standard, developed by consensus and nationally recognized.
Voluntary standards share certain important principles.
First, they are established by consensus. Note that this does not mean unanimity – standards seldom satisfy all interests equally. But they are developed using a process that ensures that all views are heard and considered, and that conflicts are resolved where possible, so that the final product represents a general agreement among all concerned parties.
Standards must be impartial, and not be used to restrict commerce. They are, after all, agreements among competitors, who must be careful not to write specifications that would squeeze another company’s product out of the market, or require product approvals available only to certain companies. Standards and certification activities fall under close scrutiny by the US Justice Department, as well as international trade agreements.
All standards establish a baseline of performance. They are seldom the leading edge of technology, but rather a set of essential performance characteristics. This enables consumers to choose from a range of products from companies that compete on design, comfort, fit, durability, appearance, cost, service etc – but not on the performance requirements.
Among safety product standards, the most familiar name is ANSI, which stands for the American National Standards Institute. But while it’s the most familiar, ANSI’s role is often misunderstood.
ANSI is a federation formed by standards writers and users, that manages the voluntary standards system in the United States. ANSI is not a government agency, although it works closely with the government, and is the official United States voice in international standards bodies. Its revenue comes from its membership, in the form of dues and fees, and from the sale of standards publications.
ANSI does not develop standards.
This comes as a surprise to a lot of people. ANSI’s role is to coordinate the activities of organizations in the US that do develop standards. ANSI approves the establishment of standards committees and new standards projects, sets the rules for the various methods that standards developers use, oversees the process, and approves the final products as American National Standards.
ANSI rules and procedures require that standards development processes incorporate the elements of openness, balance, transparency, consensus and due process.
Regardless of how a standard is drafted, it has to be offered for public review, and the sponsoring organization has to resolve the public comments before it gets ANSI approval.
Once approved, an ANSI standard has a 5-year lifetime. ANSI will withdraw approval from a standard that is not revised, rescinded or reaffirmed at least every five years.
ANSI approves the process and the standard. ANSI does not write standards, and ANSI does not approve products.
Many ANSI standards are born in trade associations, whose members have special product expertise. These groups achieve consensus through a process that involves a balanced group of producers, users, government agencies and experts. This group, unique to each standard or set of standards, may conduct its work as a committee or through correspondence. Whichever method is used, it continues to rewrite the standard until objections are resolved and a final ballot indicates consensus. Public comments are also solicited through ANSI. The association or professional society provides the secretariat, administering the process and publishing the standard.
Standards organizations such as NFPA and ASTM develop standards through technical committees, made up of experts on the product or process under review. They have their own structures and systems to achieve consensus, and generally submit their standards for public review and approval as ANSI standards as well.
The sponsoring organization’s job does not stop when the standard is approved. For example, ISEA publishes and sells the ANSI standards for which it is the secretariat, and responds to inquiries from users. Under ANSI procedures, the secretariat has sole responsibility for interpretation, and calls to ANSI about a standard are routed to the sponsoring organization. The secretariat also maintains files pertaining to its standards, and begins preparing for future revisions almost as soon as a standard is published.
International standards are developed by multinational organizations such as ISO – the International Organization for Standardization, and the International Electrotechnical Commission (IEC). In these committees, voting is done by country, and ANSI is the official US representative. Here again, ANSI itself only participates at the policy level, leaving the actual standards committee activities to be administered by groups that it designates.
There are national standards bodies like ANSI in most other countries, as well. Examples are CSA in Canada, BSI in the United Kingdom, JSA in Japan and DIN in Germany. Each of these countries may have unique requirements for PPE.
This Web site has links to many international and national standards bodies.
Standards establish requirements. A supplier needs to be able to communicate to the purchaser and user that its product, process or service conforms to a standard.
This is the purpose of conformity assessment:
- Conformity assessment is the name given to the processes that are used to demonstrate that a product, service or management system or body meets specified requirements. When applied to product, it involves testing to an established performance standard, as well as inspection, quality management, surveillance, accreditation and declaration of conformity.
PPE conformity assessment in the U.S. is a mix of manufacturer’s self-declaration, government approval and third-party certification. OSHA requires that respirators be NIOSH approved, but does not require any level of conformity assessment for other PPE.
Self-declaration is the most common approach. Manufacturers test their products, or have them tested, and declare that they meet the standard by marking or labeling the product as required by the standard, providing information in packaging, literature and advertising, and in some cases producing a written declaration of conformity.
Government certification programs include NIOSH testing and approval of respirators and breathing apparatus. These standards are imbedded in regulation, and have the force of law.
Where self-declaration will not satisfy market demand or regulatory requirements, manufacturers rely on third-party certification. In this case, an independent organization conducts ongoing testing of a product, to see if it meets the performance requirements of a recognized standard. It may also require an assessment of the company’s quality systems to ensure that the manufacturer’s internal production controls are designed and operated so that every product that comes off the line will meet the standard’s requirements. When these conditions are met, the third party grants the manufacturer the use of its certification mark. In the safety equipment marketplace, familiar certification marks include the SEI mark of the Safety Equipment Institute, the CSA mark in Canada, and marks of independent labs such as UL and Intertek. In Europe, the CE mark is used on PPE to indicate conformity with European requirements.
While this mix of conformity assessment systems has worked well over the years, it becomes a challenge in a global marketplace, where substandard look-alike PPE may bear the markings required by a standard, but fail even the most basic test. Responsible manufacturers have to compete with suppliers of these low-cost variants, and workers may be put at risk.
For this reason, ISEA developed a voluntary standard for PPE conformity assessment, which was approved as an American National Standard in February 2014, and revised in 2021. ANSI/ISEA 125-2021 establishes requirements for initial and ongoing product testing, quality assurance, recordkeeping, market surveillance, corrective action and declaration of conformity. Using this standard, suppliers of PPE have a way to document the process by which they test and evaluate products, and communicate that process to customers, without necessarily turning the process over to a third-party certification organization.
ANSI/ISEA 125-2021 presents three alternative levels of conformity assessment, which differ in the type and rigor of testing and quality assurance, from self-testing to full-blown third-party certification.
- For Level 1, the supplier tests the product in-house or at a third-party lab.
- For Level 2, the product is tested in a facility that is accredited to international standard ISO 17025, and manufactured under an ISO 9001-registered quality system. Both Level 1 and Level 2 require issuance of a supplier’s declaration of conformity.
- Level 3 of the standard is third-party certification, where the entire process from testing to surveillance is under the direction of an accredited certification body, whose mark is applied to conforming products.
The standard does not match a conformity assessment method with a specific product, hazard or performance standard, leaving that decision to the supplier, purchaser or regulatory agency.
OSHA does not certify or approve any products. Any claim that a product is “OSHA approved” is misleading.
Product standards determine performance requirements, and certification indicates conformity to standards. How those products are installed and used in the workplace falls under OSHA.
OSHA standards and regulations may mandate the use of a product that meets a standard, but not specify how that product is certified. For example, the OSHA PPE standards require that hard hats, safety glasses and safety footwear meet specific ANSI standards; the OSHA respirator standard requires that products be NIOSH approved. OSHA officials often participate in the development of those standards, and ANSI and OSHA work in close cooperation.
For some products, such as electrical products in the workplace, OSHA requires third-party approval. When this is the case, it specifies the standards to which the products must be approved, and accredits test labs to certify to those standards. These labs are designated Nationally Recognized Testing Laboratories, or NRTLs. Keep in mind, however, that OSHA does not require third-party approval for PPE. Therefore no lab – even if it is an NRTL – should claim to be recognized by OSHA to test and approve PPE.
Outside the U.S., there is far greater reliance on mandatory testing and certification.
- In Europe, for example, all PPE must be tested and display the CE mark.
- In Canada, CSA is both a standards developer and certification body, writing the standards and conducting testing to indicate conformity. This mandatory testing and certification meets the needs of a global marketplace, when nations agree to mutual acceptance of products, which can then cross borders without needing additional approvals. Because these are government-to-government agreements, the national authorities are much more involved in the process.
International standards also serve the needs of a global market, as far-flung suppliers and users are able to speak a common commercial language. Increasingly, trade agreements and treaties bind all parties – including the U.S. – to use international standards where possible in procurement and regulation.
U.S. companies and organizations participate in international standards development through Technical Advisory Groups to ISO, which has committees and working groups to develop PPE product standards. In some of these groups, the U.S. is pressing for international adoption of our domestic standards and practices. ISO and European standards also influence new U.S. standards in development.
The goal of one standard and one test, accepted worldwide, is the dream of many international businesses. But it’s probably a long way off.
When cited correctly, standards can be used by students and testifying or reporting SMEs (subject matter experts).
The follow format should be followed when citing an ISEA standard:
- Year (in round brackets).
- Standard title (in italics).
- Standard number (in round brackets).
- Publisher name.
- Homepage URL of the publisher (if a direct URL is not available for standard).
Example: International Safety Equipment Association, (2014). Emergency Eyewash and Shower Equipment (ANSI/ISEA Z358.1-2014). ISEA. https://www.safetyequipment.org/
Everything you need to know about product standards.
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