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ISO

ISO 11137:1995/Cor 1:1997

(Corrigendum)

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1

Stérilisation des dispositifs médicaux — Prescriptions pour la validation et le contrôle de routine — Stérilisation par irradiation — Rectificatif technique 1

General Information

Status
Withdrawn
Publication Date
21-May-1997
Withdrawal Date
21-May-1997
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
ISO/TC 198 - Sterilization of health care products
Drafting Committee
ISO/TC 198/WG 2 - Radiation sterilization
Current Stage
9599 - Withdrawal of International Standard
Completion Date
19-Apr-2006
Ref Project

Relations

Revised
ISO 11137-1:2006 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Effective Date
15-Apr-2008
Revised
ISO 11137-3:2006 - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
Effective Date
15-Apr-2008
Corrects
ISO 11137:1995 - Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Effective Date
06-Jun-2022
Revised
ISO 11137-2:2006 - Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Effective Date
15-Apr-2008
Child
ISO 11137:1995 - Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Effective Date
15-Apr-2008

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Standards Content (Sample)

INTERNATIONAL STANDARD IS0 11137:1995
TECHNICAL CORRIGENDUM 1
Published 1997-05-E
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION l MEXJJYHAPOjJHAfl OPrAHM3AUMfl n0 CTAH~PTM3AL/MM. ORGANISATION INTERNATIONALE DE NORMALISATION
Requirements for
Sterilization of health care products -
validation and routine control - Radiation sterilization
TECHNICAL CORRIGENDUM 1
Stkrilisa tion des dispositifs mhdica ux - Prescriptions pour la validation et le contr6le de routine - Stklisation par
irradiation
RECTIFICATIF TECHNIQUE I
Technical Corrigendum 1 to International Standard IS0 11137:1995 was prepared by Technical Committee
lSO/TC 198, Sterilization of health care products.
Page 25
B.3.4.2.2.3 Stage 3: Perform verification dose experiment
(For Method 2A) Replace the last two sentences of the first paragraph with the following text:
“The actual dose may vary from the D* kGy dose by + I,0 kGy
...

NORME INTERNATtONALE BO 11137:1995’;
RECTIFICATIF TECHNIQUE 1
=wT!z
Publié 1997-05-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION . ME>KAYHAPOUHAfl OPrAHM3ALWlfl l-l0 CTAHRAPTM3ALWlM l ORGANISATION INTERNATIONALE DE NORMALISATION
Stérilisation des dispositifs médicaux - Prescriptions pour
- Stérilisation par
la validation et le contrôle de routine
irradiation
RECTIFICATIF TECHNIQUE 1
Sterilization of health tare products - Requirements for validation and routine control - Radiation sterilization
TECHNICAL CORRIGENDUM 1
Le Rectificatif technique 1 à la Norme internationale ISO 11137:1995 a été élaboré par le comité technique
ISOKC 198, Stérilisation des produits de santé.
Page 25
B.3.4.2.2.3 Étape 3: effectuer une expérience avec la dose de vérification
(Pour la méthode 2A) Remplacer les deux dernières phrases du premier alinéa par le texte suivant:
( ...

NORME INTERNATtONALE BO 11137:1995’;
RECTIFICATIF TECHNIQUE 1
=wT!z
Publié 1997-05-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION . ME>KAYHAPOUHAfl OPrAHM3ALWlfl l-l0 CTAHRAPTM3ALWlM l ORGANISATION INTERNATIONALE DE NORMALISATION
Stérilisation des dispositifs médicaux - Prescriptions pour
- Stérilisation par
la validation et le contrôle de routine
irradiation
RECTIFICATIF TECHNIQUE 1
Sterilization of health tare products - Requirements for validation and routine control - Radiation sterilization
TECHNICAL CORRIGENDUM 1
Le Rectificatif technique 1 à la Norme internationale ISO 11137:1995 a été élaboré par le comité technique
ISOKC 198, Stérilisation des produits de santé.
Page 25
B.3.4.2.2.3 Étape 3: effectuer une expérience avec la dose de vérification
(Pour la méthode 2A) Remplacer les deux dernières phrases du premier alinéa par le texte suivant:
( ...

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