ДСТУ EN ISO 11140-1:2019 Стерилизация медицинской продукции. Химические индикаторы. Часть 1. Общие требования (EN ISO 11140-1:2014, IDT; ISO 11140-1:2014, IDT)

ДСТУ EN ISO 11140-1:2019
(EN ISO 11140-1:2014, IDT; ISO 11140-1:2014, IDT)

Стерилізація виробів медичної призначеності.
Хімічні індикатори. Частина 1. Загальні вимоги

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Categorization

4.1 General

4.2 Type 1: process indicators

4.3 Type 2: indicators for use in specific tests

4.4 Type 3: single critical process variable indicators

4.5 Type 4: multicritical process variable indicators

4.6 Type 5: integrating indicators

4.7 Type 6: emulating indicators

5 General requirements

6 Performance requirements

6.1 General

6.2 Type 1 indicators

6.3 Type 2 indicators

6.4 Types 3, 4, 5 and 6 indicators

7 Test methods

7.1 General

7.2 Off-set (transference)

7.3 Procedure - Steam indicators

7.4 Procedure - Dry heat indicators

7.5 Procedure - EO indicators

7.6 Procedure - Low temperature steam and formaldehyde indicators

7.7 Procedure - Vaporized hydrogen peroxide indicators

8 Additional requirements for process (Type 1) indicators

8.1 Process indicators printed or applied on to packaging material

8.2 Process indicators for steam sterilization processes

8.3 Process indicators for dry heat sterilization processes

8.4 Process indicators for ethylene oxide sterilization processes

8.5 Process indicators for radiation sterilization processes

8.6 Process indicators for low temperature steam and formaldehyde sterilization processes

8.7 Process indicators for vaporized hydrogen peroxide sterilization processes

9 Additional requirements for single critical process variable (Type 3) indicators

10 Additional requirements for multicritical process variable (Type 4) indicators

11 Additional requirements for steam integrating (Type 5) indicators

12 Additional requirements for ethylene oxide integrating (Type 5) indicators

13 Additional requirements for emulating (Type 6) indicators

Annex A (normative) Method for demonstrating shelf-life of the product

Annex B (informative) Examples of testing indicators

Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138 (all parts) and microbial inactivation

Annex D (informative) Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators

Annex E (informative) Relationship of indicator and indicator system components

Bibliography