Standards

Many different ways can lead to local, regional or international standards, specifications or guidance documents. In some regions, standards are an important element during the certification process. Generally, the term “standard” can have different meanings, sometimes only slight differences lead to unexpected consequences. Therefore, it is important to consider the “standards world” in which oneself needs to be active.

Respiratory standards exist on a global basis as well as in regions and countries worldwide. Many of them are currently under development or revision on different levels, in different organizations and in very diverse stages.

It is the intention of the ISRP to give guidance by supporting its members and the respiratory community with information on respiratory standards for a deeper understanding of the actual standardization situation.

Where are standards generated

When it comes to international standardization on global level, there are two important organizations:

ISO – International Organization for Standardization

IEC – International Electrotechnical Commission

Both have similar procedures and common directives, enabling countries and individuals interested in the development, use and improvement of International Standards. The organizations can be platforms for cooperation of experts on a high level.

Members of ISO or IEC are generally national standardization institutes, like BSI in the UK (British Standards Institution), JISC in Japan (日本産業標準調査会 Japanese Industrial Standards Committee) or ABNT in Brazil (Associação Brasileira de Normas Técnicas Brazilian Association for Technical Standards), to give some examples.

Each of the local standardization institutes can decide if they want to become active (participating) or passive (observing) members of Technical Committees, where the actual standardization work takes place.

Important for the European market: there exist collaborations with regional organizations like CEN, the European Committee for Standardizations (link) or CENELEC, the European Committee for Electrotechnical Standardization (link).

What is a standard

Standards, Specifications, Guides and other terms are used when describing the result of a standardization process. These definitions can be found in the ISO/IEC Directives, Part 2, 2018 (https://www.iso.org/directives-and-policies.html):

document

ISO or IEC standardization draft or publication

EXAMPLE International Standards, Technical Specifications, Publicly Available Specifications, Technical Reports and Guides.

standard

document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context

NOTE: Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits.

international standard

standard that is adopted by an international standardizing/standards organization and made available to the public

International Standard

international standard where the international standards organization is ISO or IEC

From these definitions, you can see that different types of documents (results of standardization processes) and different levels of organizational background (who publishes the resulting documents) exist.

The principle of consensus finding

A high requirement for the development of International Standards in the sense of ISO/IEC is to bring the involved parties to a

consensus

general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments

NOTE: Consensus need not imply unanimity.

[Source: ISO/IEC Guide 59:2019])

Different procedures exist to support the standards writers to find consensus.