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MedicalDevice版 - International Organization for Standardization
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发帖数: 25265
1
The International Organization for Standardization (French: Organisation
internationale de normalisation, Russian: Международная орг
анизация по стандартизации, tr. Mezhdunarodnaya
organizaciya po standartizacii),[1] widely known as ISO, is an international
standard-setting body composed of representatives from various national
standards organizations. Founded on February 23, 1947, the organization
promulgates worldwide proprietary industrial and commercial standards. It
has its headquarters in Geneva, Switzerland.[2] While ISO defines itself as
a non-governmental organization, its ability to set standards that often
become law, either through treaties or national standards, makes it more
powerful than most non-governmental organizations.[citation needed] In
practice, ISO acts as a consortium with strong links to governments.[
citation needed]
Contents
[hide]
1 Name and abbreviation
2 History
3 Financing
4 International Standards and other publications
5 Standardization process
6 ISO document copyright
7 Members
8 Products named after ISO
9 ISO/IEC Joint Technical Committee 1
10 IWA document
11 Criticism
12 Notes and references
13 See also
14 Further reading
15 External links
[edit] Name and abbreviation
The organization's logos in two of its official languages, English and
French, include the word ISO, and it is usually referred to by this short-
form name. ISO asserts that ISO is not an acronym or initialism for the
organization's full name in either official language; rather, the
organization adopted ISO based on the Greek word isos (ἴσος),
meaning equal — recognizing that the organization’s initials would be
different in different languages, the organization's founders chose ISO as
the universal short form of its name.[3] However, one of the founding
delegates, Willy Kuert, recollected the original naming question with the
comment "I recently read that the name ISO was chosen because 'iso' is a
Greek term meaning 'equal'. There was no mention of that in London!"[4]
[edit] History
The organization which today is known as ISO began in 1926 as the
International Federation of the National Standardizing Associations (ISA).
This organization focused heavily on mechanical engineering. It was
disbanded in 1942 during the second World War but was re-organized under the
current name, ISO, in 1946.
ISO is a voluntary organization whose members are recognized standard
authorities, each one representing one country. The bulk of the work of ISO
is done by the 2700 technical committees, subcommittees and working groups.
Each committee and subcommittee is headed by a Secretariat from one of the
member organizations.
[edit] Financing
ISO is funded by a combination of:[5][6]
Organizations which manage the specific projects or loan experts to
participate in the technical work.
Subscriptions from member bodies ("the national body most representative
of standardization in its country"[7]). These subscriptions are in
proportion to each country's gross national product and trade figures.
Sale of standards.
[edit] International Standards and other publications
See also: List of International Organization for Standardization standards
ISO's main products are the International Standards. ISO also publishes
Technical Reports, Technical Specifications, Publicly Available
Specifications, Technical Corrigenda, and Guides.[8][9]
International Standards are designated with the format ISO[/IEC] [/ASTM] [IS
] nnnnn[-p]:[yyyy] Title, where nnnnn is the number of the standard, p is an
optional part number, yyyy is the year published, and Title describes the
subject. IEC for International Electrotechnical Commission is included if
the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint
Technical Committee). ASTM (American Society for Testing and Materials) is
used for standards developed in cooperation with ASTM International. The
date and IS are not used for an incomplete or unpublished standard, and may
under some circumstances be left off the title of a published work.
Technical Reports are issued when "a technical committee or subcommittee has
collected data of a different kind from that which is normally published as
an International Standard".[8] such as references and explanations. The
naming conventions for these are the same as for standards, except TR
prepended instead of IS in the report's name. Examples:
ISO/IEC TR 17799:2000 Code of Practice for Information Security
Management
ISO/TR 19033:2000 Technical product documentation — Metadata for
construction documentation
Technical Specifications can be produced when "the subject in question is
still under development or where for any other reason there is the future
but not immediate possibility of an agreement to publish an International
Standard". Publicly Available Specifications may be "an intermediate
specification, published prior to the development of a full International
Standard, or, in IEC may be a 'dual logo' publication published in
collaboration with an external organization".[8] Both are named by
convention similar to Technical Reports, for example:
ISO/TS 16952-1:2006 Technical product documentation — Reference
designation system — Part 1: General application rules
ISO/PAS 11154:2006 Road vehicles — Roof load carriers
ISO sometimes issues a Technical Corrigendum. These are amendments to
existing standards because of minor technical flaws, usability improvements,
or to extend applicability in a limited way. Generally, these are issued
with the expectation that the affected standard will be updated or withdrawn
at its next scheduled review.[8]
ISO Guides are meta-standards covering "matters related to international
standardization".[8] They are named in the format "ISO[/IEC] Guide N:yyyy:
Title", for example:
ISO/IEC Guide 2:2004 Standardization and related activities — General
vocabulary
ISO/IEC Guide 65:1996 General requirements for bodies operating product
certification
[edit] Standardization process
A standard published by ISO/IEC is the last stage of a long process that
commonly starts with the proposal of new work within a committee. Here are
some abbreviations used for marking a standard with its status:[10][11][12][
13][14][15][16]
PWI - Preliminary Work Item
NP or NWIP - New Proposal / New Work Item Proposal (e.g., ISO/IEC NP
23007)
AWI - Approved new Work Item (e.g., ISO/IEC AWI 15444-14)
WD - Working Draft (e.g., ISO/IEC WD 27032)
CD - Committee Draft (e.g., ISO/IEC CD 23000-5)
FCD - Final Committee Draft (e.g., ISO/IEC FCD 23000-12)
DIS - Draft International Standard (e.g., ISO/IEC DIS 14297)
FDIS - Final Draft International Standard (e.g., ISO/IEC FDIS 27003)
PRF - Proof of a new International Standard (e.g., ISO/IEC PRF 18018)
IS - International Standard (e.g., ISO/IEC 13818-1:2007)
Abbreviations used for amendments:[10][11][12][13][14][15][16][17]
NP Amd - New Proposal Amendment (e.g., ISO/IEC 15444-2:2004/NP Amd 3)
AWI Amd - Approved new Work Item Amendment (e.g., ISO/IEC 14492:2001/AWI
Amd 4)
WD Amd - Working Draft Amendment (e.g., ISO 11092:1993/WD Amd 1)
CD Amd / PDAmd - Committee Draft Amendment / Proposed Draft Amendment (e
.g., ISO/IEC 13818-1:2007/CD Amd 6)
FPDAmd / DAM (DAmd) - Final Proposed Draft Amendment / Draft Amendment (
e.g., ISO/IEC 14496-14:2003/FPDAmd 1)
FDAM (FDAmd) - Final Draft Amendment (e.g., ISO/IEC 13818-1:2007/FDAmd 4)
PRF Amd - (e.g., ISO 12639:2004/PRF Amd 1)
Amd - Amendment (e.g., ISO/IEC 13818-1:2007/Amd 1:2007
Other abbreviations:[14][15][17][18]
TR - Technical Report (e.g., ISO/IEC TR 19791:2006)
DTR - Draft Technical Report (e.g., ISO/IEC DTR 19791)
TS - Technical Specification (e.g., ISO/TS 16949:2009)
DTS - Draft Technical Specification (e.g., ISO/DTS 11602-1)
PAS - Publicly Available Specification
TTA - Technology Trends Assessment (e.g., ISO/TTA 1:1994)
IWA - International Workshop Agreement (e.g., IWA 1:2005)
Cor - Technical Corrigendum (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)
Guide - a guidance to technical committees for the preparation of
standards
International Standards are developed by ISO technical committees (TC) and
subcommittees (SC) by a process with six steps:[12][19]
Stage 1: Proposal stage
Stage 2: Preparatory stage
Stage 3: Committee stage
Stage 4: Enquiry stage
Stage 5: Approval stage
Stage 6: Publication stage
The TC/SC may set up working groups (WG) of experts for the preparation of a
Working Drafts. Subcommittees may have several working groups, which can
have several Sub Groups (SG).[20]
Stages in the development process of an ISO standard[11][12][13][16][17][19]
Stage code↓ Stage↓ Associated document name↓ Abbreviations↓
Description↓
00 Preliminary stage Preliminary work item PWI
10 Proposal stage New work item proposal NP or NWIP, NP Amd/TR/
TS/IWA
20 Preparatory stage Working draft(s) AWI, AWI Amd/TR/TS, WD, WD
Amd/TR/TS
30 Committee stage Committee draft(s) CD, CD Amd/Cor/TR/TS,
PDAmd (PDAM), PDTR, PDTS
40 Enquiry stage Enquiry draft DIS, FCD, FPDAmd, DAmd (DAM),
FPDISP, DTR, DTS (CDV in IEC)
50 Approval stage Final draft International Standard FDIS, FDAmd
(FDAM), PRF, PRF Amd/TTA/TR/TS/Suppl, FDTR
60 Publication stage International Standard ISO TR, TS, IWA, Amd
, Cor
90 Review stage ISO TR, TS, IWA, Amd, Cor
95 Withdrawal stage
It is possible to omit certain stages, if there is a document with a certain
degree of maturity at the start of a standardization project - for example
a standard developed by another organization. ISO/IEC Directives allow also
the so-called "Fast-track procedure". In this procedure a document is
submitted directly for approval as a draft International Standard (DIS) to
the ISO member bodies or as a final draft International Standard (FDIS) if
the document was developed by an international standardizing body recognized
by the ISO Council.[12]
The first step - a proposal of work (New Proposal) is approved at the
relevant subcommittee or technical committee (e.g., SC29 and JTC1
respectively in the case of Moving Picture Experts Group - ISO/IEC JTC1/SC29
/WG11). A working group (WG) of experts is set up by the TC/SC for the
preparation of a Working Draft. When the scope of a new work is sufficiently
clarified, some of the working groups (e.g., MPEG) usually make open
request for proposals - known as "Call for proposals". The first document
that is produced for example for audio and video coding standards is called
a Verification Model (VM) (previously also called a Simulation and Test
Model). When a sufficient confidence in the stability of the standard under
development is reached, a Working Draft (WD) is produced. This is in the
form of a standard but is kept internal to working group for revision. When
a Working Draft is sufficiently solid and the working group is satisfied
that it has developed the best technical solution to the problem being
addressed, it becomes Committee Draft (CD). If it is required, it is then
sent to the P-members of the TC/SC (National Bodies) for ballot.
The CD becomes Final Committee Draft (FCD) if the number of positive votes
is above the quorum. Successive committee drafts may be considered until
consensus is reached on the technical content. When it is reached, the text
is finalized for submission as a draft International Standard (DIS). The
text is then submitted to National Bodies for voting and comment within a
period of five months. It is approved for submission as a final draft
International Standard (FDIS) if a two-thirds majority of the P-members of
the TC/SC are in favour and not more than one-quarter of the total number of
votes cast are negative. ISO will then hold a ballot with National Bodies
where no technical changes are allowed (yes/no ballot), within a period of
two months. It is approved as an International Standard (IS) if a two-thirds
majority of the P-members of the TC/SC is in favour and not more than one-
quarter of the total number of votes cast are negative. After approval, only
minor editorial changes are introduced into the final text. The final text
is sent to the ISO Central Secretariat which publishes it as the
International Standard.[10][12]
[edit] ISO document copyright
ISO documents are copyrighted and ISO charges for copies of most. ISO does
not, however, charge for most draft copies of documents in electronic format
. Although useful, care must be taken using these drafts as there is the
possibility of substantial change before it becomes finalized as a standard.
Some standards by ISO and its official U.S. representative (and the
International Electrotechnical Commission's via the U.S. National Committee)
are made freely available.[21][22]
[edit] Members
A map of standards bodies who are ISO members
Key:
members
correspondent members
subscriber members
other places with an ISO 3166-1 code who aren't members of ISO
ISO has 162 national members,[2] out of the 203 total countries in the world.
ISO has three membership categories:
Member bodies are national bodies that are considered to be the most
representative standards body in each country. These are the only members of
ISO that have voting rights.
Correspondent members are countries that do not have their own standards
organization. These members are informed about ISO's work, but do not
participate in standards promulgation.
Subscriber members are countries with small economies. They pay reduced
membership fees, but can follow the development of standards.
Participating members are called "P" members as opposed to observing members
which are called "O" members.
[edit] Products named after ISO
The fact that many of the ISO-created standards are ubiquitous has led, on
occasion, to common use of "ISO" to describe the actual product that
conforms to a standard. Some examples of this are:
Many CD images end in the file extension "ISO" to signify that they are
using the ISO 9660 standard filesystem as opposed to another file system -
hence CD images are commonly referred to as "ISOs". Virtually all computers
with CD-ROM drives can read CDs that use this standard. Some DVD-ROMs also
use ISO 9660 filesystems.
Photographic film's sensitivity to light, its "film speed", is described
by ISO 5800:1987. Hence, the film's speed is often referred to as its "ISO
number."
[edit] ISO/IEC Joint Technical Committee 1
Main article: ISO/IEC JTC1
To deal with the consequences of substantial overlap in areas of
standardization and work related to information technology, ISO and IEC
formed a Joint Technical Committee known as the ISO/IEC JTC1. It was the
first such joint committee. The second joint committee was created in 2009 -
Joint Project Committee - Energy efficiency and renewable energy sources -
Common terminology (ISO/IEC/JTC 2).[23]
[edit] IWA document
Like ISO/TS, International Workshop Agreement (IWA) is another armory of ISO
for providing rapid response to requirements for standardization in areas
where the technical structures and expertise are not currently in place[
citation needed]. The utility harmonizes technical urgency industrial wide.
[edit] Criticism
With the exception of a small number of isolated standards,[24] ISO
standards are normally not available free of charge, but for a purchase fee,
[25] which has been seen by some as too expensive for small open source
projects.[26]
The ISO/IEC JTC1 fast-track procedures ("Fast-track" as used by OOXML and "
PAS" as used by OpenDocument) have garnered criticism in relation to the
standardization of Office Open XML (ISO/IEC 29500). Martin Bryan, outgoing
Convenor of ISO/IEC JTC1/SC34 WG1, is quoted as saying:
I would recommend my successor that it is perhaps time to pass WG1’s
outstanding standards over to OASIS, where they can get approval in less
than a year and then do a PAS submission to ISO, which will get a lot more
attention and be approved much faster than standards currently can be within
WG1.
The disparity of rules for PAS, Fast-Track and ISO committee generated
standards is fast making ISO a laughing stock in IT circles. The days of
open standards development are fast disappearing. Instead we are getting '
standardization by corporation'.[27]
Computer security entrepreneur and Ubuntu investor, Mark Shuttleworth,
commented on the Standardization of Office Open XML process by saying
I think it de-values the confidence people have in the standards setting
process,
and Shuttleworth alleged that ISO did not carry out its responsibility. He
also noted that Microsoft had intensely lobbied many countries that
traditionally had not participated in ISO and stacked technical committees
with Microsoft employees, solution providers and resellers sympathetic to
Office Open XML.
When you have a process built on trust and when that trust is abused,
ISO should halt the process ... ISO is an engineering old boys club and
these things are boring so you have to have a lot of passion … then
suddenly you have an investment of a lot of money and lobbying and you get
artificial results. The process is not set up to deal with intensive
corporate lobbying and so you end up with something being a standard that is
not clear.[28]
[edit] Notes and references
^ a b The 3 official full names of ISO can be found at the beginning of
the foreword sections of the PDF document: ISO/IEC Guide 2:2004
Standardization and related activities — General vocabulary
^ a b c "About ISO". ISO. Retrieved 2011-05-16.
^ "ISO - Discover ISO: ISO's name". ISO. 2010. Retrieved 2010-11-07.
^ Willy Kuert (1997). "The Founding of ISO (excerpt of Friendship Among
Equals)". ISO. Retrieved 2011-02-11.
^ "General information on ISO". ISO. Retrieved 2011-05-15.
^ "ISO in figures for the year 2010 (at 31 December)". ISO. Retrieved
2011-05-16.
^ "Member bodies". ISO. Retrieved 2011-05-15.
^ a b c d e The ISO directives are published in two distinct parts:
* "ISO Directives, Part 2: Rules for the structure and drafting of
International Standards. 5th Edition" (pdf). ISO/IEC. 2004. Archived from
the original on 10 July 2007. Retrieved 7 September 2007.
^ ISO. "ISO/IEC Directives and ISO supplement". Retrieved 1 January 2010.
^ a b c "About MPEG". chiariglione.org. Retrieved 13 December 2009.
^ a b c ISO. "International harmonized stage codes". Retrieved 31
December 2009.
^ a b c d e f ISO. "Stages of the development of International Standards
". Retrieved 31 December 2009.
^ a b c "The ISO27k FAQ - ISO/IEC acronyms and committees". IsecT Ltd..
Retrieved 31 December 2009.
^ a b c ISO (2007). "ISO/IEC Directives Supplement — Procedures
specific to ISO" (PDF). Retrieved 31 December 2009.
^ a b c ISO (2007). "List of abbreviations used throughout ISO Online".
Retrieved 31 December 2009.
^ a b c "US TAG COMMITTEE HANDBOOK" (DOC). 2008-03. Retrieved 1 January
2010.
^ a b c ISO/IEC JTC1 (2 November 2009), Letter Ballot on the JTC 1
Standing Document on Technical Specifications and Technical Reports,
retrieved 1 January 2010
^ ISO. "ISO deliverables". Retrieved 9 April 2010.
^ a b ISO (2008) (PDF), ISO/IEC Directives, Part 1 - Procedures for the
technical work, Sixth edition, 2008, retrieved 1 January 2010
^ ISO, IEC (5 November 2009). "ISO/IEC JTC 1/SC 29, SC 29/WG 11
Structure (ISO/IEC JTC 1/SC 29/WG 11 - Coding of Moving Pictures and Audio)"
. Retrieved 7 November 2009.
^ "Freely Available ISO Standards". ISO. Last updated 2007-08-08.
Retrieved 7 September 2007.
^ "Free ANSI Standards". Archived from the original on 3 April 2007.
Retrieved 19 June 2007.
^ "ISO/IEC/JTC 2 - Joint Project Committee - Energy efficiency and
renewable energy sources - Common terminology". Retrieved 1 January 2010.
^ "Freely Available Standards". ISO. Retrieved 26 April 2008.
^ "Shopping FAQs". ISO. Retrieved 26 April 2008.
^ Jelliffe, Rick (1 August 2007). "Where to get ISO Standards on the
Internet free". oreillynet.com. Retrieved 26 April 2008. "The lack of free
online availability has effectively made ISO standard irrelevant to the (
home/hacker section of the) Open Source community"
^ "Report on WG1 activity for December 2007 Meeting of ISO/IEC JTC1/SC34
/WG1 in Kyoto". iso/jtc1 sc34. 29 November 2007.
^ "Ubuntu’s Shuttleworth blames ISO for OOXML’s win". ZDNet.com. 1
April 2008.
[edit] See also
American National Standards Institute (ANSI)
Deutsches Institut für Normung, German Institute for Standardization (
DIN)
British Standards Institution (BSI)
Countries in International Organization for Standardization
Canadian Standards Association
European Committee for Standardization (CEN)
Commonwealth of Independent States (CIS) set of standards (GOST)
International Classification for Standards
International Electrotechnical Commission (IEC) and ISO/IEC standards
International healthcare accreditation
International Telecommunication Union (ITU)
Institute of Environmental Sciences and Technology (IEST)
ISO A4
ISO country code
List of International Organization for Standardization standards

ISO divisions
ISO/TC 37
ISO/TC 68
TC 46/SC 9
ISO/TC 211
ISO/TC 215
ISO/TC 223
Standardization
Standards Australia
Standards organization
Terminology planning policy
The International Customer Service Institute (TICSI)
AP Stylebook (Associated Press Style)
Interface 2010 (Interface Marketing Supplier Integration Institute)
[edit] Further reading
JoAnne Yates & Craig N. Murphy: Coordinating International Standards:
The Formation of the ISO, MIT Inovations and Enterpreneurship Seminar Series
[1], Fall 2006.
[edit] External links
Official website (free access to the catalogue of standards only, not to
the contents)
Publicly Available Standards (free access to a small subset of the
standards)
ISO/TC 37 "Terminology and other language and content resources", a
fundamental committee for all ISO standardization projects
ISO/IEC JTC1
ISO Advanced search for standards and/or projects
ISO Concept Database (terminology database of ISO standards)
http://en.wikipedia.org/wiki/International_Organization_for_Sta
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话题: iso话题: iec话题: standards话题: technical