EN ISO 11137-2:2015/prA1

SLOVENSKI STANDARD
SIST EN ISO 11137-2:2015/oprA1:2021
01-marec-2021
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka
sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/DAmd 1:2021)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose

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

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Amendment 1 to ISO 11137-2:2013 was prepared by Technical Committee ISO/TC 198, Sterilization of

Any feedback or questions on this document should be directed to the user’s national standards body. A

6.4 If a sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy is established in accordance with

b) Method 1 (see Clause 7), subject to the derived sterilization dose taking a value less than or equal

c) Method 2 (see Clause 8), subject to the derived sterilization dose taking a value less than or equal

d) a method providing equivalent assurance to that of a), b) or c) above in achieving maximally an SAL

Rationale and methods for substantiation of sterilization doses of 15 and 25 kGy using Method VD

are provided below. Rationale and methods for substantiation of sterilization doses of 17,5, 20, 22,5,

This European Standard has been prepared under a mandate given to CEN/CENELEC by the European

Commission and the European Free Trade Association to provide a means of conforming to Essential

Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the normative

clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard,

a presumption of conformity with the corresponding Essential Requirements of that Directive and

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that

risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users

of this standard should consult frequently the latest list published in the Official Journal of the

WARNING 2 — Other Union legislation may be applicable to the products falling within the scope

This European Standard has been prepared under a mandate given to CEN/CENELC by the European

Commission and the European Free Trade Association to provide a means of conforming to Essential

Once this standard is cited in the Official Journal of the European Union under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the normative

clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard,

a presumption of conformity with the corresponding Essential Requirements of that Directive and

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that

risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

Table ZB.1 — Correspondence between this European Standard and EU Directive 93/42/EEC