ISO INTERNATIONAL STANDARD 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices Stérilisation des produits de santé Chaleur seche Exigences pour I'elaboration, la validation et le controle de routine d'un processus de sterilisation pour dispositifs médicaux Reference number ISO 20857:2010(E) @ ISO 2010 ISO 20857:2010(E) Contents Page Foreword Introduction ..vi 1 Scope. 1.1 Inclusions.. 1.2 Exclusions.... 2 Normative references... 3 Terms and definitions. 4 Quality management system elements ... 10 4.1 4.2 Management responsibility .. 4.3 Product realization .... 10 4.4 Measurement, analysis and improvement - Control of nonconforming product..... 10 5 Sterilizing agent characterization. 11 5.1 Sterilizing agent.... 5.2 Microbicidal effectiveness... 11 5.3 Material effects .... 5.4 Environmentalconsiderations...... 11 6 Process and equipment characterization.............. 11 6.1 Process characterization.... 6.2 Equipment characterization . 7 Product definition.. 13 7.1 13 7.2 Product safety and performance .. 7.3 Packaging considerations.. 14 7.4 Microbiological quality... 14 7.5 Product family... 14 7.6 Biological safety . 14 8 Process definition 9 Validation 9.1 General 16 9.2 Installation qualification . 16 9.3 Operational qualification ... 16 9.4 Performance qualification .. ..16 9.5 Additional sterilization systems . 18 9.6 Review and approval of validation 18 10 Routine monitoring and control 19 10.1 Routine control... 19 10.2 Routine monitoring ... ..19 10.3 Process monitoring locations.... 20 11 Product release from sterilization/depyrogenation .... 21 12 Maintaining process effectiveness 21 12.1 General 21 12.2 Recalibration.. 21 12.3 Maintenance of equipment . 21 12.4 Requalification.. 21 12.5 Assessment of change . .22 IsO 2010-All rights reserved ili ISO 20857:2010(E) Annex A (informative) Guidance on the application of this International Standard Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) ... ...46 Annex C (informative) Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach).... Annex D (informative) Conservative process definition based on inactivation of reference microorganisms (overkill method.......... .51 Annex E (informative) Process development. Bibliography.. .57 iv @ ISO 2010 - All rights reserved ISO 20857:2010(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through ISO non-governmental, in liaison with isO, also take part in the work. isO collaborates closely ywith the InternationalElectrotechnicalCommission(lEC)onallmattersofelectrotechnicalstandardization. International Standards are drafted in accordance with the rules given in the IsO/lEc Directives, Part 2 The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 20857 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. @IsO2010-Allrightsreserved ISO 20857:2010(E) Introduction A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for development,validation androutine control of sterilization processes,require,when it is necessaryto supplyasterilemedicaldevice,thatadventitiousmicrobiological contamination of a