Scope, object and relationship to other standards

1.201 Scope This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).

NOTE: Some systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 60601-1 or the definition of MEDICAL ELECTRICAL SYSTEM in 2.203 of IEC 60601-1-1.

1.202

This Collateral Standard specifies requirements for the process by which a PEMS is designed. This Collateral Standard also serves as the basis of requirements of Particular Standards, including serving as a guide to SAFETY requirements for the purpose of reducing and managing RISK. This Collateral Standard is addressed to:

a) certification bodies; b) MANUFACTURERS; c) writers of Particular Standards

This standard covers:

d) requirement specification; e) architecture; f) detailed design and implementation including software development; g) modification; h) VERIFICATION and VALIDATION; j) marking and ACCOMPANYING DOCUMENTS

Aspects not covered by this standard include:

k) hardware manufacturing; l) software replication; m) installation and commissioning; n) operation and maintenance; o) decommissioning

1.203 Relationship to other standards

1.203.1 IEC 60601-1

For MEDICAL ELECTRICAL EQUIPMENT, this Collateral Standard complements IEC 60601-1 and its amendments.

When referring to IEC 60601-1 or to this Collateral Standard, either individually or in combination, the following conventions are used:

-"The General Standard" designates IEC 60601-1 alone; -"this Collateral Standard" designates IEC 60601-1-4 alone; -"this Standard" designates the combination of the General Standard and this Collateral Standard.

1.203.2 Particular Standards

A requirement in a Particular Standard takes priority over the corresponding requirement in this Collateral Standard.

1.203.3 Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.

IEC 60601-1:1988, Medical electrical equipment - Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995)

IEC 60601-1-1:1992, Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral Standard: Safety requirements for medical electrical systems

IEC 60788:1984, Medical radiology - Terminology

ISO 9000-3:1991, Quality management and quality assurance standards -Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software

ISO 9001:1994, Quality systems - Model for quality assurance in design, development, production, installation and servicing

1 Domaine d'application, objet et reference a d'autres normes

1.201 Domaine d'application

La presente Norme Collaterale traite de la SECURITE des APPAREILS ELECTROMEDICAUX et des SYSTEMES ELECTROMEDICAUX comprenant des SOUS-SYSTEMES ELECTRONIQUES PROGRAMMABLES (SEEP), appeles SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP) dans la suite du texte.

NOTE Certains systemes qui comportent un logiciel et sont utilises pour des besoins medicaux ne sont pas dans le domaine d'application de la presente Norme Collaterale, comme c'est le cas de plusieurs systemes d'informatique medicale. Le facteur/ critere de distinction est la conformite ou non-conformite du systeme a la definition de l'APPAREIL ELECTROMEDICAL en 2.2.15 de la CEI 60601-1 ou a la definition du SYSTEME ELECTRO-MEDICAL en 2.203 de la CEI 60601-1-1

1.202 Objet

La presente Norme Collaterale fixe les prescriptions a suivre lors de la conception d'un SEMP. Elle fournit aussi la base des prescriptions des Normes Particulieres en servant de guide pour les exigences de SECURITE visant a reduire et a gerer les RISQUES. La presente Norme Collaterale s'adresse

a) aux organismes de certification; b) aux CONSTRUCTEURS; c) aux redacteurs de Normes Particulieres

La presente norme traite les aspects suivants:

d) les specifications des prescriptions; e) l'architecture; f) la conception detaillee et la mise en oeuvre y compris le developpement du logiciel; g) les modifications; h) la VERIFICATION et la VALIDATION; j) le marquage et les DOCUMENTS D'ACCOMPAGNEMENT

La presente norme ne traite pas les aspects suivants:

k) la fabrication du materiel informatique; l) la reproduction du logiciel: m) l'installation et la mise en service; n) le fonctionnement et la maintenance; o) le retrait du service

1.203 References a d'autres normes

1.203.1 CEI 60601-1

Pour les APPAREILS ELECTROMEDICAUX, la presente Norme Collaterale complete la CEI 60601-1 et ses amendements.

Quand il est fait reference a la CEI 60601-1 ou a la presente Norme Collaterale, soit seules, soit ensemble, les conventions suivantes sont utilisees: - La Norme Generale designe la CEI 606011 seule; -la presente Norme Collaterale designe la CEI 60601-1-4 seule; -la presente Norme designe l'ensemble de la Norme Generale et de la presente Norme Collaterale.

1.203.2 Normes Particulieres

Une prescription d'une Norme Particuliere a priorite sur la prescription correspondante de la presente Norme Collaterale.

1.203.3 References normatives

Les documents normatifs suivants contiennent des dispositions qui, par suite de la reference qui y est faite, constituent des dispositions valables pour la presente Norme internationale. Au moment de la publication, les editions indiquees etaient en vigueur. Toute norme est sujette a revision et les parties prenantes aux accords fondes sur la presente Norme internationale sont invitees a rechercher la possibilite d'appliquer les editions les plus recentes des documents normatifs indiques ci-apres. Les membres de la CEI et de l'ISO possedent le registre des Normes internationales en vigueur.

CEI 60601-1:1988, Appareils electromedicaux - Premiere partie: Regles generales de securite Amendement 1 (1991) Amendement 2 (1995)

CEI 60601-1-1:1992, Appareils electromedicaux - Premiere partie: Regles generales de securite - 1. Norme Collaterale: Regles de securite pour systemes electromedicaux

CEI 60788:1984, Radiologie medicale - Terminologie

ISO 9000-3:1991, Normes pour la gestion de la qualite et l'assurance de la qualite -Partie 3: Lignes directrices pour l'application de l'ISO 9001 au developpement, a la mise a disposition et a la maintenance du logiciel

ISO 9001:1994, Systemes qualite - Modele pour l'assurance de la qualite en conception, developpement, production, installation et prestations associees