Standardization and Safety Equipment

Standards are an important part of the world of safety equipment. Manufacturers need them to determine the performance requirements for products they design, make and sell, and the test procedures to assess conformity to those requirements. Sellers, purchasers and users need them to select the right product for the job, and understand its application and limitations. Government agencies incorporate them into workplace safety and health regulations.

But even though standards are a familiar part of everyday commerce, there are some common misconceptions about them. Did you know that ANSI doesn’t develop standards? That no product can ever be "ANSI approved" or "OSHA approved?" Who is responsible for developing and maintaining standards? How does a product become "approved?" Where does the user go for answers?

The following is quick overview of standards, certification and regulation – what they are, how they are related, and how they apply to safety equipment. If you’d like more information, check out the links to other standards-related websites, or contact ISEA.

First of all, what is a standard?
Where do standards come from?
What is ANSI?
Who develops ANSI standards?
Who else develops standards?
What is certification?
Where does OSHA fit in?
How do products get approved around the world?

Here’s one definition:

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. Impact.gif (21389 bytes)

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 5.5 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 Z89.1-2003, class E.

That’s why we say 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.

And they 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.

For more information, check ANSI's website at www.ansi.org

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.

ANSI standards may be developed by accredited organizations such as ASTM or NFPA, by accredited standards committees such as Z87 (administered by ISEA), or by trade associations and professional societies through the canvass method.

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.

Many ANSI standards are born in trade associations, whose members have special product expertise. These groups may achieve consensus through the canvass method. For example, ANSI standards for head protection, emergency eyewash and shower equipment, first aid, and other products are drafted by ISEA product groups, then sent for review to a balanced list of producers, users, government agencies and experts. The group considers the canvassees’ comments, and continues to rewrite the standard until all the objections are resolved and a final ballot indicates consensus. Public comments are also solicited through ANSI.
	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.
Still other standards, such as Z87.1 for safety eyewear, Z359 and A10.32 for fall protection, and the Z88 standards for respiratory protection, are developed by accredited standards committees. These semi-independent committees strive for a balance of producer, user, government, and other interests. They are administered by a member of the committee – generally an association or professional society – which provides the secretariat. 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.
Remember: ANSI approves the process, and the standard. ANSI does not write standards, and ANSI does not approve products.

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 certification.

The process of certification involves testing to an established standard, and providing a mark or some other indication of conformity.

Certification testing may be done by a government agency such as NIOSH, FDA or MSHA; the product manufacturer, either at its own facility or a contract testing lab, or by an independent third-party assessor.

Government certification programs exist in the US mostly when public health and safety are involved. For example, the FDA tests and certifies new drugs and medical devices before they are allowed on the market, and NIOSH tests and certifies respirators and breathing apparatus.

In the U.S., manufacturer’s self-certification is the most common approach. Manufacturers test their products, or have them tested, and declare that they meet the standard. This may be a label on the product - often in a form required by the standard - as well as information provided in packaging, literature and advertising.

This system often seems mysterious to the rest of the world, accustomed to more rigorous government oversight and regulation. But self-certification works in the US for several reasons. We have a legal system that severely penalizes products that don't measure up, a consumer base that’s generally well-informed and vigilant, a market large enough to give those consumers a wide choice of products, and laws that govern truth in labeling and advertising.

Where self-certification will not satisfy the 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.

This is the most common method of certification outside the US, and in some US markets as well. For example, the UL mark of Underwriters Laboratories is familiar on electrical products. In the safety equipment marketplace, the most familiar certification marks are the SEI mark of the Safety Equipment Institute, the CSA mark in Canada, and the CE mark that indicates conformity with European requirements.

SEI is the only third-party certification organization in this country dedicated to safety equipment. Its programs cover industrial safety equipment, fire and rescue equipment, and some sports equipment such as bicycle and riding helmets. SEI was founded by ISEA in 1981, but is now completely independent.

For each product in its program, SEI has selected a nationally recognized standard, a qualified laboratory to do the testing, and a quality systems auditor. Products that pass display the SEI label, and their manufacturers undergo periodic follow-up testing and quality audits.

Keep in mind that SEI is not the only testing body for PPE, and SEI certified products are not necessarily superior to products whose manufacturers self-certify.

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.

Remember:
OSHA does not certify or approve any products. Any claim that a product is "OSHA approved" is misleading.

Outside the US, 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 US – to use international standards where possible in procurement and regulation. US 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 US is pressing for international adoption of our domestic standards and practices. ISO and European standards also influence new US 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.