ДСТУ CEN ISO/TS 17665-2:2014 Стерилизация медицинских изделий. Влажный жар. Часть 2. Руководство по применению ISO 17665-1 (CEN ISO/TS 17665-2:2009, IDT)



ДСТУ CEN ISO/TS 17665-2:2014
(CEN ISO/TS 17665-2:2009, IDT)

Стерилізація медичних виробів. Вологий жар.
Частина 2. Настанова із застосування ISO 17665-1

 
   
 
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 Quality management system elements

5 Sterilizing agent characterization

5.1 Sterilizing agent

5.2 Microbicidal effectiveness

5.3 Material effects

5.4 Environmental considerations

6 Process and equipment characterization

6.1 Process

6.2 Equipment

7 Product definition

8 Process definition

9 Validation

9.1 General

9.2 Installation qualification (IQ)

9.3 Operational qualification (OQ)

9.4 Performance qualification (PQ)

9.5 Review and approval of the validation

10 Routine monitoring and control

11 Product release from sterilization

12 Maintaining process effectiveness

12.1 Demonstration of continued effectiveness

12.2 Recalibration

12.3 Maintenance of equipment

12.4 Requalification

12.5 Assessment of change

Annex A (informative) Evaluation of a sterilization process primarily based on the measurement of physical parameters

Annex В (informative) Evaluation of a sterilization process primarily based on biological inactivation and an accompanying mechanical air removal procedure

Annex C (informative) Temperature and pressure of saturated steam for use in moist heat sterilization

Annex D (informative) Special considerations for health care settings

Annex E (informative) Index of normative clauses/subclauses of ISO 17665-1 and cited references or related guidance given in ISO 17665-1 and ISO/TS 17665-2

Bibliography