ISO 16061:2021 Instruments for use in association with non-active surgical implants — General requirements

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Instruments for use in association with non-active surgical implants — General requirements是ISO于2021-03发布的ISO标准，适用于世界范围。

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Instruments for use in association with non-active surgical implants — General requirements

1 Scope

This document specifies the general requirements for instruments to be used in association with non-

active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.

NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 25424, Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 80000-1, Quantities and units — Part 1: General

3 Terms a nd definiti ons

For the purposes of this document, the terms and definitions given in ISO 14971 and the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www.e lectropedia .org/ — ISO Online browsing platform: available at https:// www .iso .org/ obp

3.1

associated implant

specific non-active surgical implant (3.4) associated with a specific instrument (3.3) intended to be used during a surgical procedure

3.2

f i na l i n s t r u ment

instrument (3.3) that has been subjected to all manufacturing processes for the “to be marketed” instrument including packaging and if applicable, sterilization

Note 1 to entry: Derived from the definition of “final product” in ISO 10993-1:2018, 3.8 to reinforce that the instrument to be evaluated is the final product referred to in ISO 10993-1.

3.3

instrument

non-active medical device intended for use during surgical procedures related to specific non-active surgical implants (3.4)

Note 1 to entry: Examples of typical applications of instruments to be used in association with non-active surgical implants are presented in A.1.

3.4

non-active surgical implant

surgical implant, the operation of which does not depend on a source of electrical energy or any source of power other than that directly generated by the human body or gravity

[SOURCE: ISO 14630:2012, 3.6, modified — the second term "implant" has been deleted.]

4 Intended performance

The intended performance of an instrument shall be described and documented by addressing the following, with particular regard to safety:

a) intended purpose;

b) functional characteristics;

c) intended conditions of use.

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