ISO11135两个版本的比较.docx

1、ISO11135两个版本的比较Clause2014Influence20071 ScopeNothing significant change for the industrial1.1 InclusionNEWSpecify requirement of EO sterilization for industrial and health care facility.1.2 ExclusionNEW1.2.1=2007 1, DO NOT include several kinds of inactivation 1.2.2=2007 1, DO NOT specify requiremen

2、t for designating STERILE1.2.3=2007 1, DO NOT specify a quality management system1.2.4=2007.1, DO NOT specify occupational safety1.2.5=2007.1, DO NOT include injecting EO to package1.2.6=2007.1, DO NOT cover analytical method for EO residual or reaction2 Normative ReferenceISO 10012, sameISO 10993-1

3、 DELETEISO 10993-7 sameISO 11138-1:2006 sameISO 11138-2:2009 version updateISO 11140-1 sameISO 11737-1 sameISO 11737-2 sameISO 13485:2003/Cor 1:2009, changeISO 14161 DELETEISO 14937:2000DELETE3 Term and DefinitionDew Point: NEWHealth care facility: NEWOverkill approach: only term changeProcess chall

4、enge device: internal PCD/external PCDProcessing category: NEWProduce family: NEWReusable medical device: NEWSingle use medical device: NEWSLR: new method to calculateSterile barrier system: NEWSterilization specialist: NEWTest for sterility: NEWVirgin material: NEW4 Quality management system4.1 Doc

5、umentation4.1.1=2007 4.1.1, procedure for development, validation, routine control and product release shall be specified.4.1.2=2007 4.1.2, reviewed and approved by designated personnel, document and record according to ISO 13485No effect4.2 Management responsibility4.2.1=2007 4.2.1, responsibility

6、and authority shall be specified according to ISO 134854.2.2=2007 4.2.2, organization with separate quality management systemAdd HCFs responsibilityNo effect4.3 Production realization4.3.1=2007 4.3.1, purchasing procedure4.3.2=2007 4.3.2, procedure for identification and traceability4.3.3=2007 4.3.3

7、, quality management system for calibrationNo effect4.4 Measurement, analysis and improvement=2007 4.4, procedure for nonconforming product and for correction, corrective action and preventive action.No effect5 Sterilizing agent characterization5.1 GeneralNEWPurpose5.2 Sterilizing agent=2007 5.1, co

8、mposition, storageDescription change while the content keep the same5.3 Microbicidal effectiveness=2007 5.2, recognized range of EO and diluents, otherwise microbicidal effectiveness shall be developed.5.4 Material effects=2007 5.3, EOs effect on materials used to Medical Device.DELETE the descripti

9、on of recording5.5 Safety and environment5.5.1, NEW, MSDS of EO and diluents needed, health and safety of personnel5.5.2=2007 5.4.1, environmentprotect5.5.3=2007 5.4.2, user of EO6 Process and equipment characterization6.1 General6.1.1, NEW, purpose 6.1.2, NEW, if a sterilization process existing, t

10、hen ignore this6.2 Process characterization6.2.1, NEW, Process characterization shall includea), identifying the phase for EO cycleb), identifying the variables for each phasec) document the variables6.2.2=2007 6.1.2, phase of sterilizationa), preconditioningb), sterilization cyclec), aeration6.2.3,

11、NEW, variables for preconditioninga), timeb), tempc), humidityd), transfer time6.2.4,NEW, variable for sterilization cyclea), exposure timeb), tempc), humidityd), EO concentratione), pressure6.2.5, NEW, variable for aeration, note for aeration variablea), timeb), tempDELETE 2007 6.1.1 DELETE 2007 6.

12、1.3 the characterization of sterilization cycleDELETE 2007 6.1.4 the controlled treatment conditionDELETE 2007 6.1.5 toleranceDELETE 2007 6.1.6 means of monitoring and controlling Range of variable and equipment shall be documented6.3 Equipment characterization6.3.1=2007 6.2.1, specification of equi

13、pment shall includea), the preconditioning areab), the sterilizerc), the aeration area6.3.2=2007 6.2.2, specification shall includea)=2007 a), description of equipment, ancillary items, material of constructionb)2007 b), description of means of delivering sterilizing agent to chamberc)=2007 c), desc

14、ription of means of delivering other gas or steam to chamberd)=2007 e), description of instrumentation for monitoring, controlling and recordinge)=2007 f), fault recognitionf)=2007 g), safety featureg)=2007 h), installation requirement6.3.3=2007 6.2.3, software shall be prepared and validated to mee

15、t its specification6.3.4=2007 6.2.4, means to ensure failure in control function does not lead to failure in recording which lead to a fake positive7 Product definition7.1 General7.1.1,NEW, purpose: define the product to be sterilized prior to the sterilization, including the microbiological quality

16、 and package7.1.2=2007 7.1.1+7.1.27.1.32007 7.1.5, It can be achieved by 3 ways to demonstrate the specified sterilization process is effective in sterilizing the most difficult-to-sterilize location within the product instead of may be.7.2 Product safety, quality and performance7.2.1=2007 7.2.1, th

17、e most challenging process parameter of product and package.7.2.22007 7.4, documentation shall be done by manufacturer of the device8 Process definition8.1 NEW, purpose, obtain a process specification for the sterilization of product during the validation studies.8.2 =2007 8.1+8.3, sterilization sha

18、ll be established for new or modified product, packaging or loading configuration.8.3 =2007 8.2, sterilization chamber shall be IQed and OQed.8.4 =2007 8.4, documentation and records8.5 =2007 8.5, rate of microbiological inactivation shall be determined by the method provided in annexes or alternati

19、ve method achieving the same SAL8.6 =2007 8.6, BI and PCD requirement8.7 =2007 8.7, commercially supplied BI requirement shall comply with 8.6 and ISO 11138-18.8 =2007 8.8, chemical indicators shall comply with ISO 11140-18.9 =2007 8.9, test of sterility shall comply with ISO 11737-29 Validation9.1

20、GeneralNew9.1.1, Purpose, validation consists of 3 stages: IQ, OQ, PQ.9.1.2 ,Purpose of IQ9.1.3, Purpose of OQ9.1.4, Purpose of PQ, difference of IOQ and PQ9.2 IQ=2007 9.19.2.1 EquipmentNew9.2.1.1 =2007 9.1.1 and 9.1.29.2.1.2, New safety standard9.2.1.3=2007 9.1.39.2.2 IQNew9.2.2.1, architectural an

21、d engineering drawing and regulation9.2.2.2=2007 9.1.5, instruction for installation and health and safety of personnel9.2.2.3, safe EO storage=2007 9.1.4 Example9.2.2.4, calibration9.2.2.5=2007 9.1.6 drawing of equipment shall be finalized during IQ.9.2.2.6, change of system shall be assessed and d

22、ocumented in DHF9.3 OQ9.3.1=2007 9.2.1, calibration of instrumentation9.3.2=2007 9.2.2, equipment is capable of meeting its operating specification.9.4 PQ9.4.1 General9.4.1.1, PQ consists of microbiological and physical PQ9.4.1.2=2007 9.3.1.1, when to perform PQ9.4.1.3=2007 9.3.1.2, object used in P

23、Q9.4.1.4=2007 9.3.1.4+9.3.1.3, manner of presenting product and loading pattern shall be specified and the sealable product requirement9.4.1.5=2007 9.3.1.3, load requirement9.4.1.6=2007 9.49.4.1.7=2007 9.3.1.3, material other than product9.4.1.8=2007 9.3.1.3, reused load9.4.1.9=2007 9.3.1.5, chemica

24、l indicator comply with ISO 11140-1 and conjunction with microbiological and physical monitoring9.4.1.10, BI comply with ISO111389.4.2 PQ-Microbiological9.4.2.1=2007 9.3.2.1, MPQ shall demonstrate specified requirement for sterility is met on application of the sterilization process.9.4.2.2=2007 9.3

25、.2.2, MPQ shall confirm the effectiveness of defined process9.4.2.3=2007 9.3.2.3, Lethality of process shall be determined using the method in annex or alternative method with achieving the required SAL9.4.2.4=2007 9.3.2.4, developmental chamber requirement9.4.2.5, overkill half cycle approach, inte

26、rnal and external PCD requirement9.4.2.6, overkill cycle calculation approach or BI/bioburden approach, internal PCD and SAL requirement9.4.3 PQ-Physical9.4.3.12007 9.3.3.1, Physical PQ shall demonstrate the reproducibility and specified acceptance criteria is met.9.4.3.22007 9.3.3.2, PPQ shall conf

27、irm the process a) add the minimum temp of product to enter the cycleb)=2007 a), load temp at the end of preconditioning timec)=2007 b), maximum time between completion of preconditioning and commencement of cycled) add the load temp and humidity and the end of conditioninge) add the humidity is rec

28、orded if parametric release was to be usedf)=2007 c), gaseous EO is admitted to the chamberg)=2007 d), pressure rise, quality and concentration of EO recorded if parametric release is to be usedh)=2007 e), temp and humidity of the chamber and other parameter is recorded if parametric release is to be usedi)=2007 f), temp of load during EO exposurej)=2007 g), temp of load during aeration9.5 Review and approval of validation9.5.1=2007 9.5.1, purpose9.5.2=200