ISO 10993-7:2026(en) Contents Page Foreword. iv Introduction..V 1Scope.1 2Normative references.1 3Terms and definitions1 4Requirements.5 4.1General..5 4.2Categorization of devices...6 4.3Allowable limits...6 4.3.1General..6 4.3.2Limited exposure devices..8 4.3.3Prolonged exposure devices..9 4.3.4Long-term exposure devices..9 4.3.5Special situations..11 4.3.6Tolerable contact level.12 4.4Determination of EO and ECH residuals.12 4.4.1Procedure.12 4.4.2Test method validation.12 4.4.3Product sampling.12 4.4.4Sample/fluid ratios.13 4.4.5Product extraction.13 4.4.6Multi-device systems.13 5Productrelease13 5.1General.13 5.2Batch release of products.14 5.3Release of products at specifiedminimumaerationtime.14 5.4Procedure for product release using residual dissipation curves.14 6Adoption of products into established aeration family15 7Change evaluation..15 Annex A (informative) Guidance for the application of this document for the determination of EO and ECH residuals in medical devices16 Annex B (informative) Factors influencing product residuals.27 Annex C (informative) Rationale for the provisions of this document.30 Annex D (informative) Establishment of allowable limits for EO.38 Annex E (informative) Establishment of allowable limits for ECH.56 Annex F (informative) Ethylene glycol66 Annex G (normative) Evaluation of gas chromatograms.70 Annex H (informative) Gas chromatographic determination for EO and ECH.74 Annex I (informative) Preparation of EO and ECH standards78 Annex J (informative) Ethylene oxide and ethylene chlorohydrin residual measuring methods.82 Annex K (informative) Examples of product release methods.90 Bibliography.109
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ISO 10993-7:2026(en) 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 technical mittees. Each member body interested in a subject for which a technical mittee has been established has the right to be represented on that mittee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives,Part 1. In particular, the different approval criteria needed for the different types ISO/IEC Directives, Part 2 (see of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISo had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at ISO shall not be held responsible for identifying any or all such patent rights. Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principlesin the Technical Barriers to Trade (TBT), see This document was prepared byTechnical Committee ISO/TC 194,Biological andclinical evaluation ofmedical devices, in collaboration with the European Committee forStandardization (CEN) Technical Committee CEN/ TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This third edition cancels and replaces the second edition (ISO 10993-7:2008), which has been technically ISO 10993-7:2008/Cor 1:2009. revised. It also incorporates the Amendment ISO 10993-7:2008/Amd 1:2019 and the Technical Corrigendum The main changes are as follows: -allowable limits and extraction conditions have been derived based on the patient population and the duration of use; - the use of a risk assessment to establish allowable limits has been permitted; additional guidance on product release has been provided; - additional guidance on determining residuals and the factors that affect residual has been provided. A list of all parts in the ISO 10993 series can be found on the ISO website. plete listing of these bodies can be found at
@ ISO 2026 All rights reserved iv
ISO10993-7:2026(en) Introduction As noted in the introduction to ISO 11135, when determining the suitabili...
引言
正如《ISO11135》导言中所指出的那样，在确定环氧乙烷(EO)是否适用于医疗器械的灭菌处理时重要的是要确保残留的EO和环氧氯丙烷(ECH)水平不会对预期产品使用中的患者造成显著风险因此，在产品设计和开发过程中考虑使用替代材料和灭菌工艺是十分必要的。EO已被证实具有多种生物效应。在编制本文件的过程中，对这些效应进行了考量，其中包括对人及动物的刺激性、器官损伤、诱变性、致癌性及生殖影响。同样被考虑的还有ECH和乙二醇(EG)的有害影响。ECH可能是在E0与游离氯离子接触时形成的，而EG是EO与水发生水解反应的产物。在实践中，对于大多数设备而言，接触EO和ECH的程度远低于根据本文件设定的最大允许限值。对于EG并未设定任何允许限值，因为风险评估表明，当EO残留物得到控制时，不太可能存在具有生物学意义的EG残留物。
本文件中的相关要求是对IS010993-1中生物评价要求的补充。生物评价结果，结合EO灭菌工艺残留限值，构成了证明EO灭菌设备在其预期接触时间内安全的依据。对于ECH(当ECH已被发现存在于使用E0进行灭菌的医疗设备中时)的最大允许残留量也作了明确规定。局部效应(如刺激性)已被考虑并纳入了TCL中，具体参见4.3.6.2和附录D中关于EO的内容，以及4.3.6.3和附录E中关于ECH的内容。
在本版文件(即ISO10993-7:2026)中，采用不确定性系数方法推导出EO和ECH暴露持续时间特定可耐受摄入量(TI)值(以克/千克/天为单位)。此外，本版文件(即IS010993-7:2026)还介绍了将每个EO和ECHTI值转换为子群体特定累积暴露-允许限值(以每件设备毫克为单位)的转换过程，这些限值用于确定在临床相关条件和时段下提取的EO和ECH在灭菌后需要降低的程度。
本版文件(即ISO 10993-7:2026)在确立可接受值方面采用了与ISO 10993-17:2023不同的方法，使其适用于成品医疗器械制造过程中环氧乙烷灭菌工艺的研制、验证和常规控制，重点在于评估与可能残留在经环氧乙烷灭菌处理的医疗器械中的三种化学成分相关的风险。本文件通过计算医疗器械中可存在的最大量EO、ECH或EG来进一步拓展这一知识领域，以确保当该器械已暴露于经验证的灭菌周期参数时，始终能满足IS010993-17的相关要求。这一最大量或允许限值以每件设备的毫克数表示，同时考虑到设备中的通气温度和保持时间，这些参数在验证用于某产品或某类产品群的灭菌工艺时至关重要。此外，监管机构、制造商和加工商均可利用这些允许限值来优化工艺，并协助选择及认证替代材料，从而保护患者健康。
