ДСТУ EN ISO 11138-7:2022 Стерилизация изделий медицинского назначения. Биологические индикаторы. Часть 7. Руководства по выбору, использованию и интерпретации результатов (EN ISO 11138-7:2019, IDT; ISO 11138-...



ДСТУ EN ISO 11138-7:2022
(EN ISO 11138-7:2019, IDT; ISO 11138-7:2019, IDT)

Стерилізація виробів медичногопризначення. Біологічні індикатори.
Частина 7. Настанови щодо вибору, використання та інтерпретації результатів

 

 
   
 
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 General

5 Characteristics of biological indicators

5.1 General

5.2 Test organism suspension for direct inoculation of products

5.3 Inoculated carriers

5.4 Self-contained biological indicators

6 Selection of supplier

6.1 General

6.2 Documentation

7 Biological indicators in process development

7.1 General

7.2 Overkill approach

7.3 Combined biological indicator and bioburden method

7.4 Bioburden method

8 Biological indicators in sterilization validation

8.1 General

8.2 Placement and handling of biological indicators

8.3 Sterilizer qualification

8.4 Performance qualification

8.5 view and approval of validation 8.6 Requalification

9 Biological indicators in routine monitoring

9.1 General

9.2 lacement and handling of biological indicators

9.3 Process challenge device

10 Interpretation and acceptance criteria

10.1 General

10.2 Interpretation of results

11 Application of biological indicator standards

11.1 General assessment of biological indicator performance by the user

11.2 Nominal population of test organism

11.3 Resistance determination

11.4 z value determination

11.5 F(T, z) equivalent sterilization value determination

11.6 Establishing spore-log-reduction

11.7 Sterility assurance level calculation

11.8 Test equipment

12 Culture conditions

12.1 General

12.2 Incubation temperature

12.3 Incubation period

12.4 Choice of growth medium

13 Third-party considerations

13.1 General

13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators

13.3 Test equipment

14 Personnel training

15 Storage and handling

16 Disposal of biological indicators

Annex A Microbiological inactivation kinetics and enumeration techniques

Annex B (informative) Process challenge devices

Annex C (informative) Formulae for D value determination by fraction-negative method

Annex D (informative) Examples of documentation for biological indicators prepared by the user

Annex E (informative) Calculation of z value

Annex F (informative) D value determination by survivor curve method

Annex G (informative) Survival-kill response characteristics

Bibliography