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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Withdrawn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
Start Date
19-Apr-2006
Completion Date
13-Dec-2025
Ref Project

Relations

Corrects
ISO 11137:1995 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
Effective Date
06-Jun-2022
Revised
ISO 11137-1:2006 - 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 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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
Child
ISO 11137:1995 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
Effective Date
15-Apr-2008
ISO 11137:1995/Cor 1:1997ISO 11137:1995/Cor 1:1997
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Frequently Asked Questions

ISO 11137:1995/Cor 1:1997 is a standard published by the International Organization for Standardization (ISO). Its full title is "Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization - Technical Corrigendum 1". This standard covers: 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

ISO 11137:1995/Cor 1:1997 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 11137:1995/Cor 1:1997 has the following relationships with other standards: It is inter standard links to ISO 11137:1995, ISO 11137-1:2006, ISO 11137-2:2006, ISO 11137-3:2006; is excused to ISO 11137:1995. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase ISO 11137:1995/Cor 1:1997 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.

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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