Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

PQ will be followed by a parallel FV (CC/020326)
the prlongation 3 years dow is currently asked under CMC resolution 2003-06-19_CMC1. CMC has evidence from emails that full concensus has been reached amongst the members and associates to ask for it. Therefore this 3 years transition period has to appear claerly where it applies on the document published. For further informations please contact ludwig paul at the number +32(0)25500831.

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003)

1.1 Allgemeines
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation ihre Fähigkeit zur Bereitstellung von Medizinprodukten und zugehörigen Dienstleistungen darzulegen hat, die ständig die Anforderungen der Kunden und die für Medizinprodukte und zugehörige Dienstleistungen zutreffenden gesetzlichen Anforderungen erfüllen.
Das primäre Ziel dieser Internationalen Norm ist die Ermöglichung der Harmonisierung der für Medizinprodukte zutreffenden gesetzlichen Anforderungen an Qualitätsmanagementsysteme. Im Ergebnis dessen enthält sie einige besondere Anforderungen an Medizinprodukte und schließt einige Anforderungen von ISO 9001 aus, die nicht als Anforderungen für gesetzliche Zwecke geeignet sind. Wegen dieser Ausschlüsse können Organisationen, deren Qualitätsmanagementsysteme dieser Internationalen Norm entsprechen, keine Konformität mit ISO 9001 beanspruchen, außer wenn ihr Qualitätsmanagementsystem mit allen Anforderungen von ISO 9001 konform ist (siehe Anhang B).
1.2 Anwendung
Alle Anforderungen dieser Internationalen Norm sind spezifisch für Organisationen, die Medizinprodukte zur Verfügung stellen, unabhängig von Art und Größe der Organisation.
Wenn regulatorische Anforderungen Ausschlüsse von Lenkungsmaßnahmen zu Design und Entwicklung (siehe 7.3) zulassen, kann dies als Begründung für deren Ausschluss aus dem Qualitätsmanagementsystem verwendet werden. Diese Bestimmungen können alternative Vorkehrungen vorsehen, die in das Qualitätsmanagementsystem eingehen müssen. Es liegt in der Verantwortung der Organisation, sicherzustellen, dass der Ausschluss von Lenkungsmaßnahmen des Designs und der Entwicklung sich in den Ansprüchen auf Konformität mit dieser Internationalen Norm widerspiegelt [siehe 4.2.2a) und 7.3].
Wenn wegen der Art des Medizinprodukts oder der Medizinprodukte, auf die das Qualität-smanagement-system angewendet wird, eine oder mehrere Anforderungen in Abschnitt 7 dieser Internationalen Norm

Dispositifs médicaux - Systemes de manegement de la qualité - Exigences a des fins réglementaires (ISO 13485:2003)

L'ISO 13485:2003 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des clients et aux exigences réglementaires applicables aux dispositifs médicaux et aux services associés.
Le principal objectif de l'ISO 13485:2003 est de faciliter la mise en oeuvre d'exigences réglementaires harmonisées en matière de dispositifs médicaux, dans le cadre des systèmes de management de la qualité. Par conséquent, elle comprend certaines exigences particulières concernant les dispositifs médicaux, mais certaines exigences de l'ISO 9001, non appropriées en tant qu'exigences réglementaires, en sont exclues. Du fait de ces exclusions, les organismes dont les systèmes de management de la qualité sont conformes à l'ISO 13485:2003 ne peuvent revendiquer la conformité à l'ISO 9001 que si leurs systèmes de management de la qualité sont conformes à l'ensemble des exigences de l'ISO 9001.
Toutes les exigences de l'ISO 13485:2003 sont spécifiques aux organismes fournissant des dispositifs médicaux, indépendamment du type ou de la taille de l'organisme.
Le fait que des exigences réglementaires autorisent l'exclusion des systèmes de contrôle de conception et de développement peut servir à justifier leur exclusion du système de management de la qualité. Ces réglementations peuvent prévoir d'autres dispositions qui doivent être appliquées dans le système de management de la qualité. Il incombe à l'organisme de s'assurer que ses demandes de conformité à l'ISO 13485:2003 correspondent à l'exclusion des systèmes de contrôle de conception et de développement.
Lorsqu'une ou plusieurs exigences définies à l'Article 7 de l'ISO 13485:2003 ne peuvent être appliquées en raison de la nature du ou des dispositifs médicaux auxquels s'applique le système de management de la qualité, l'organisme n'est pas tenu d'inclure cette (ces) exigence(s) dans son système de management de la qualité.
Les processus requis par l'ISO 13485:2003, qui sont applicables au(x) dispositif(s) médical (médicaux) mais non adoptés par l'organisme, relèvent de la responsabilité de ce dernier qui en tient compte dans son système de management de la qualité.

Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003)

General Information

Status
Withdrawn
Publication Date
31-Oct-2003
Withdrawal Date
12-Mar-2012
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
13-Mar-2012
Due Date
05-Apr-2012
Completion Date
13-Mar-2012

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SLOVENSKI STANDARD
SIST EN ISO 13485:2003
01-november-2003
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SIST EN ISO 13485:2002
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Medical devices - Quality management systems - Requirements for regulatory purposes

(ISO 13485:2003)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2003)

Dispositifs médicaux - Systemes de manegement de la qualité - Exigences a des fins

réglementaires (ISO 13485:2003)
Ta slovenski standard je istoveten z: EN ISO 13485:2003
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 13485:2003 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 13485
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2003
ICS 03.120.10; 11.040.01 Supersedes EN ISO 13485:2000 and EN ISO 13488:2000
English version
Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)

Dispositifs médicaux - Systèmes de manegement de la Qualitätssicherungssysteme - Medizinprodukte -

qualité - Exigences à des fins réglementaires (ISO Systemanforderungen zur Erfüllung gesetzlicher

13485:2003) Anforderungen (ISO 13485:2003)
This European Standard was approved by CEN on 16 June 2003.

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 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 Management Centre has the same status as the official

versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13485:2003 E

worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 13485:2003 (E)
Foreword

The text of the International Standard ISO 13485:2003 has been prepared by Technical

Committee ISO/TC 210 "Quality management and corresponding general aspects for medical

devices, Working Group 1". The transposition into a European Standard has been managed by

the CEN Management Centre (CMC) with the assistance of the CEN/CENELEC Co-ordinating

Working Group on quality supplements for medical devices.
This European Standard supersedes EN ISO 13485:2000 and EN ISO 13488:2000.

This European Standard shall be given the status of a national standard, either by publication of

an identical text or by endorsement, at the latest by January 2004, and conflicting national

standards shall be withdrawn at the latest by July 2006.

This document has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association, and supports essential requirements of EU

Directive(s).

For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this

document.

NOTE The following is specifically intended for organisations that need to comply with

one or more of the “New Approach” European Directives for medical devices

(90/385/EEC, 93/42/EEC, and 98/79/EC) in order to affix CE marking on their products and

to other parties involved in that process.

The publication of EN ISO 13485:2003 has implications for Council Decision 93/465/EEC of 22

July 1993 concerning the modules for the various phases of the conformity assessment

procedures and the rules for affixing and use of the CE conformity marking, which are intended

to be used in the technical harmonization directives. It is important to note that the modules used

in individual technical harmonization directives may vary in some respects compared to those

described in Council Decision 93/465/EEC. In all cases, it is the annex of the applicable

directive(s) which is legally binding. The principles set out in this foreword remain valid

regardless of these variations.

Two of the modules cited in Council Decision, i.e. modules D and H, require that “the

manufacturer must operate an approved quality system”. The scope of the quality systems

required by these modules addresses:
- Production, final inspection and testing (module D),
- Design manufacture and final product inspection and testing (module H).

Where organizations wish to implement quality management systems in conformance with

modules D or H, they may use EN ISO 13485:2003. In seeking compliance with modules D or H

organizations may exclude specific requirements.

Where organizations wish to implement quality management systems in conformance with

module E, they may use EN 46003:1999 (which is in the process of being revised into the format

of EN ISO 13485:2003)
---------------------- Page: 3 ----------------------
EN ISO 13485:2003 (E)
Module D Module H
Permissible exclusions Permissible exclusions
Sub-clause 7.3: design and development NO exclusions permitted

Module D is the basis for annex V of 93/42/EEC directive and the basis for annex VII of

98/79/EC directive.

Module H is the basis for annex 2 of 90/385/EEC directive, for annex II of 93/42/EEC directive

and for annex II of 98/79/EC directive.

It should be noted that EN ISO 13485:2003 is a Quality Management System for medical

devices specifically for regulatory purposes. It is based on EN ISO 9001:2000 but in particular

the requirements for “customer satisfaction” and “continual improvement” have been modified.

Therefore, while EN ISO 13485:2003 has the same format as EN ISO 9001:2000 and most of

the same requirements, compliance with EN ISO 13485:2003 does not provide conformity with

EN ISO 9001:2000.

It should be noted that where the exclusions described in sub-clause 1.2 of EN ISO 13485:2003

are exceeded, conformity to EN ISO 13485:2003 shall not be claimed.

According to CEN/CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Czech

Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and

the United Kingdom.
Endorsement notice

The text of ISO 13485:2003 has been approved by CEN as EN ISO 13485:2003 without any

modifications.

NOTE Normative references to International Standards are listed in Annex ZA (normative).

---------------------- Page: 4 ----------------------
EN ISO 13485:2003 (E)
Annex ZA
(normative)
Normative references to international publications with their corresponding
European publications

This European Standard incorporates, by dated or undated reference, provisions from other

publications. These normative references are cited at the appropriate places in the text, and the

publications are listed hereafter. For dated references, subsequent amendments to or revisions of

any of these publications apply to this European Standard only when incorporated in it by

amendment or revision. For undated references the latest edition of the publication referred to

applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),

the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 9000 2000 Quality management systems – EN ISO 9000 2000
Fundamentals and vocabulary
---------------------- Page: 5 ----------------------
EN ISO 13485:2003 (E)
Annex ZB
(informative)
Relationship of this document with EC Directives

This document has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association and supports essential requirements of EC

Directive(s) :
- EC Directive 93/42/E(E)C

Compliance with this document provides one means of conforming with the specific essential

requirements of the Directive concerned and associated EFTA regulations.

WARNING: Other requirements and other EC Directives may be applicable to the product(s)

falling within the scope of this document.

The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.

---------------------- Page: 6 ----------------------
INTERNATIONAL ISO
STANDARD 13485
Second edition
2003-07-15
Medical devices — Quality management
systems — Requirements for regulatory
purposes
Dispositifs médicaux — Systèmes de management de la qualité —
Exigences à des fins réglementaires
Reference number
ISO 13485:2003(E)
ISO 2003
---------------------- Page: 7 ----------------------
ISO 13485:2003(E)
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ii © ISO 2003 — All rights reserved
---------------------- Page: 8 ----------------------
ISO 13485:2003(E)
Contents Page

Foreword............................................................................................................................................................ iv

0 Introduction ........................................................................................................................................... v

0.1 General................................................................................................................................................... v

0.2 Process approach ................................................................................................................................. v

0.3 Relationship with other standards ..................................................................................................... vi

0.4 Compatibility with other management systems ............................................................................... vi

1 Scope...................................................................................................................................................... 1

1.1 General................................................................................................................................................... 1

1.2 Application............................................................................................................................................. 1

2 Normative references ........................................................................................................................... 2

3 Terms and definitions........................................................................................................................... 2

4 Quality management system ............................................................................................................... 4

4.1 General requirements ........................................................................................................................... 4

4.2 Documentation requirements .............................................................................................................. 4

5 Management responsibility.................................................................................................................. 6

5.1 Management commitment.................................................................................................................... 6

5.2 Customer focus..................................................................................................................................... 6

5.3 Quality policy......................................................................................................................................... 6

5.4 Planning ................................................................................................................................................. 7

5.5 Responsibility, authority and communication................................................................................... 7

5.6 Management review.............................................................................................................................. 8

6 Resource management......................................................................................................................... 8

6.1 Provision of resources ......................................................................................................................... 8

6.2 Human resources.................................................................................................................................. 9

6.3 Infrastructure......................................................................................................................................... 9

6.4 Work environment................................................................................................................................. 9

7 Product realization.............................................................................................................................. 10

7.1 Planning of product realization ......................................................................................................... 10

7.2 Customer-related processes.............................................................................................................. 10

7.3 Design and development.................................................................................................................... 11

7.4 Purchasing........................................................................................................................................... 13

7.5 Production and service provision ..................................................................................................... 14

7.6 Control of monitoring and measuring devices ................................................................................ 17

8 Measurement, analysis and improvement........................................................................................ 17

8.1 General................................................................................................................................................. 17

8.2 Monitoring and measurement............................................................................................................ 18

8.3 Control of nonconforming product ................................................................................................... 19

8.4 Analysis of data................................................................................................................................... 19

8.5 Improvement........................................................................................................................................ 20

Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996........................... 21

Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 ............ 25

Bibliography ..................................................................................................................................................... 57

© ISO 2003 — All rights reserved iii
---------------------- Page: 9 ----------------------
ISO 13485:2003(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding

general aspects for medical devices.

This second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically

revised. It also cancels and replaces ISO 13488:1996. Those organizations which have used ISO 13488 in the

past may use this International Standard by excluding certain requirements in accordance with 1.2.

This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer

requirements, and other elements of quality system management.
iv © ISO 2003 — All rights reserved
---------------------- Page: 10 ----------------------
ISO 13485:2003(E)
0 Introduction
0.1 General

This International Standard specifies requirements for a quality management system that can be used by an

organization for the design and development, production, installation and servicing of medical devices, and

the design, development, and provision of related services.

It can also be used by internal and external parties, including certification bodies, to assess the organization’s

ability to meet customer and regulatory requirements.

Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.

It is emphasized that the quality management system requirements specified in this International Standard

are complementary to technical requirements for products.

The adoption of a quality management system should be a strategic decision of an organization. The design

and implementation of an organization's quality management system is influenced by varying needs,

particular objectives, the products provided, the processes employed and the size and structure of the

organization. It is not the intent of this International Standard to imply uniformity in the structure of quality

management systems or uniformity of documentation.

There is a wide variety of medical devices and some of the particular requirements of this International

Standard only apply to named groups of medical devices. These groups are defined in Clause 3.

0.2 Process approach

This International Standard is based on a process approach to quality management.

Any activity that receives inputs and converts them to outputs can be considered as a process.

For an organization to function effectively, it has to identify and manage numerous linked processes.

Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and

interactions of these processes, and their management, can be referred to as the “process approach”.

0.3 Relationship with other standards
0.3.1 Relationship with ISO 9001
While this is a stand-alone standard, it is based on ISO 9001.

Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font. The

fact that these subclauses are presented unchanged is noted in Annex B.

Where the text of this International Standard is not identical to the text of ISO 9001, the sentence or indent

containing that text as a whole is shown in italics (in blue italics for electronic versions). The nature and

reasons for the text changes are noted in Annex B.
© ISO 2003 — All rights reserved v
---------------------- Page: 11 ----------------------
ISO 13485:2003(E)
0.3.2 Relationship with ISO/TR 14969

ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.

0.4 Compatibility with other management systems

This International Standard follows the format of ISO 9001 for the convenience of users in the medical device

community.

This International Standard does not include requirements specific to other management systems, such as

those particular to environmental management, occupational health and safety management, or financial

management.

However, this International Standard enables an organization to align or integrate its own quality management

system with related management system requirements. It is possible for an organization to adapt its existing

management system(s) in order to establish a quality management system that complies with the

requirements of this International Standard.
vi © ISO 2003 — All rights reserved
---------------------- Page: 12 ----------------------
INTERNATIONAL STANDARD ISO 13485:2003(E)
Medical devices — Quality management systems —
Requirements for regulatory purposes
1 Scope
1.1 General

This International Standard specifies requirements for a quality management system where an organization

needs to demonstrate its ability to provide medical devices and related services that consistently meet

customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of this International Standard is to facilitate harmonized medical device regulatory

requirements for quality management systems. As a result, it includes some particular requirements for

medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory

requirements. Because of these exclusions, organizations whose quality management systems conform to

this International Standard cannot claim conformity to ISO 9001 unless their quality management systems

conform to all the requirements of ISO 9001 (see Annex B).
1.2 Application

All requirements of this International Standard are specific to organizations providing medical devices,

regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used

as a justification for their exclusion from the quality management system. These regulations can provide

alternative arrangements that are to be addressed in the quality management system. It is the responsibility

of the organization to ensure that claims of conformity with this International Standard reflect exclusion of

design and development controls [see 4.2.2 a) and 7.3].

If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of the

medical device(s) for which the quality management system is applied, the organization does not need to

include such a requirement(s) in its quality management system [see 4.2.2 a)].

The processes required by this International Standard, which are applicable to the medical device(s), but

which are not performed by the organization, are the responsibility of the organization and are accounted for

in the organization’s quality management system [see 4.1 a)].

In this International Standard the terms “if appropriate” and “where appropriate” are used several times. When

a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization

can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for

 the product to meet specified requirements, and/or
 the organization to carry out corrective action.
© ISO 2003 — All rights reserved 1
---------------------- Page: 13 ----------------------
ISO 13485:2003(E)
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000 apply, together with the

following.

The following terms, used in this edition of ISO 13485 to describe the supply chain, have been changed to

reflect the vocabulary currently used:
supplier -------------> organization ----------> customer

The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to the unit to which

this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean

“service”.

Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to

related services as supplied by the organization.

The following definitions should be regarded as generic, as definitions provided in national regulations can

differ slightly and take precedence.
3.1
active implantable medical device

active medical device which is intended to be totally or partially introduced, surgically or medically, into the

human body or by medical intervention into a natural orifice, and which is intended to remain after the

procedure
3.2
active medical device

medical device relying for its functioning on a source of electrical energy or any source of power other than

that directly generated by the human body or gravity
3.3
advisory notice

notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary

information and/or to advise what action should be taken in
 the use of a medical device,
 the modification of a medical device,
 the return of the medical device to the organization that supplied it, or
 the destruction of a medical device

NOTE Issue of an advisory notice might be required to comply with national or regional regulations.

2 © ISO 2003 — All rights reserved
---------------------- Page: 14 ----------------------
ISO 13485:2003(E)
3.4
customer complaint

written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability,

reliability, safety or performance of a medical device that has been placed on the market

3.5
implantable medical device
medical device intended

 to be totally or partially introduced into the human body or a natural orifice, or

 to replace an epithelial surface or the surface of the eye,

by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which

can only be removed by medical or surgical intervention

NOTE This definition applies to implantable medical devices other than active implantable medical devices.

3.6
labelling
written, printed or graphic matter
 affixed to a medical device or any of its containers or wrappers, or
 accompanying a medical device,

related to identification, technical description, and use of the medical device, but excluding shipping

documents

NOTE Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer.”

3.7
medical device

any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,

material or other similar or related article, intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purpose(s) of
 diagnosis, prevention, monitoring, treatment or alleviation of disease,

 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

 investigation, replacement, modification, or support of the anatomy or of a physiological process,

 supporting or sustaining life,
 co
...

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