Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1

ISO 11608-1:2022/DAmd 1

ISO 11608-1:2022/DAmd 1: Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1

ISO 11608-1:2022/DAM 1:2025(en)

ISO/TC 84/WG 3 N 698

Replaces N 697

Secretariat: DS

Date: 2025-06-03

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

AMENDMENT 1

Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — Partie 1: Systèmes d'injection à aiguille

AMENDEMENT 1

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Contents

Foreword iv

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 committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. 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 of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and catheters.

This amendment addresses editorial inconsistencies with regards to terminology introduced in the last revision, e.g. use of "anticipated/normal conditions" vs. "in-use conditions" and interchangeable and inconsistent use of "conditioning" and "preconditioning".

In addition, it tries to improve subclause 10.2 with regards to the sequence of visual inspection and assessment of primary functions.

It does not introduce new requirements, and it does not change existing requirements.

A list of all parts in the ISO 11608 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
AMENDMENT 1

5.7.2 Primary functions requirements

Replace the first paragraph with the following:

Primary functions shall be identified through an assessment of each design specification (see Figure H.2 for an example assessment process). At minimum, primary functions shall include the dose delivery function, as specified by the dose accuracy requirements.

6.1 General

Replace the first two paragraphs with the following:

Any suitable test system can be used for the measurement of primary functions of the NIS, when the required accuracy (calibration) and precision (Gauge R&R) can be obtained. The repeatability and reproducibility (Gauge R&R) of the test apparatus shall be no greater than 20 % of the specification range for any given measurement. For one-sided specifications, the other endpoint shall be established to create a specification range for the assessment of the apparatus (i.e. not as a specification limit for assessment of the design). For destructive test measurements, the Gauge R&R shall be no greater than 30 % of the specification range. At a minimum, the Gauge R&R should cover ±2 standard deviations (thereby covering approximately 95 % of the variation).

NOTE An extra endpoint for one-sided specifications can be based on physical limitations of the NIS or the measurement system (e.g. noting that a duration of time cannot be negative), or be based on the distribution of the measurement results (e.g. setting the end-point six times the standard deviation from the mean).

7.2.2 Dosing regions

Replace NOTE 1 with:
	NOTE 1 If the sum of the doses set is greater than or equal to half the deliverable volume of the container, the container can be divided into two regions.

9 Test case matrix

Replace the first paragraph with the following:

Table 3 summarizes test requirements for the system designations described in 5.2. The testing procedures, including stressed/challenge conditions (see 10.3) and normal/anticipated conditions (see 10.2), are described in Clause 10.

10.1 General

Replace the subclause with the following:

For each test case described in Clause 10, perform the required testing/evaluations after exposure to each stressed/challenge condition (see 10.3) or at normal/anticipated condition (see 10.2) .

Unless otherwise instructed for a given test description, the actual testing/evaluation shall be performed at standard atmosphere conditions in accordance with 10.2.1.1.

Although the order of the evaluations, a) through b) is unspecified, it is recommended that the inspection (a) be performed after the NIS has been subjected to stressed/challenge conditions (see 10.3) and/or before the NIS is tested for primary functions (b) at normal/anticipated conditions (see 10.2). Inspection at this point is consistent with the state of the NIS when it is inspected before use by the user.

a) Perform inspection of every NIS in accordance with Clause 11.

b) Assess primary functions of the NIS in accordance with 5.7.2 and Clause 7. The NIS shall maintain its primary functions after being subjected to stressed/challenge conditions (see 10.3) or at normal/anticipated conditions (see 10.2) described in Clause 10. For the last-dose accuracy test described in 10.2.2, only dose accuracy is required.

For NISs that may operate for extended durations, it shall be considered simulating additional conditions to which the NIS would be subjected as worn before and/or during delivery in addition to the conditioning specified as "normal/anticipated conditions" when testing primary functions.

In accordance with 5.7.1, testing (other than for primary functions – see 5.7.2) shall be conducted at standard atmosphere without any exposure to stressed/challenge conditions, unless the normal use case of the product indicates an alternative test condition.

NOTE See Annex A for test conditions.

10.2.1.1 Atmosphere conditions

Replace the first paragraph with the following:

The assembled NIS with the filled container but without needle (if removable) is placed in a test chamber to condition for at least 4 h in the atmospheres given in Table 4.

Annex A:

A.3.2.3 Life-cycle testing (see 10.2.3)

Replace the subclause with the following:

Life-cycle testing is intended to verify the primary functions of the NIS at normal/anticipated conditions (see 10.2) after the delivery of 1,5 times the maximum number of actuations expected during its lifetime. 1,5 provides a reasonable safety factor above the expected duty cycle of the NIS. This test does not address storage during the period of time between manufacture and first use by the patient.

Annex D:

D.2.1 General

Replace the subclause with the following:

Functional stability represents the overall lifetime of the product and includes the time that elapses from the point of manufacture of the final finished product, and release into the supply chain up through the point of first use (shelf-life) and the actual use of the product in the hands of users up to the point of last operational use and disposal (in-use life). Functional stability includes a combination of the shelf-life and the in-use life. The labelled shelf life (or expiration date) of the NIS is the date after which the NIS should not be used. The in-use life of the NIS represents the amount of time, uses and conditions which the NIS is labelled to be used for. The intent is that the NIS meets its primary functions at the end of its stated shelf and in-use life. Unless determined by risk assessment, it is expected that all testing will be performed on the NIS at normal/anticipated conditions (see 10.2), not subjected to any stressed/challenge conditions (see 10.3) before testing.

Annex H:

H.1 General

Replace the 6th paragraph with the following:

Because primary functions are identified early in the design process based on unacceptable harm per this document, before mitigations have been implemented, this document requires that they be subjected to a more extensive verification, i.e. at normal/anticipated conditions (see 10.2) and after exposure to stressed/challenge conditions (see 10.3) specified in this document, which had been only applied to dose accuracy in previous revisions.

Replace the 8th paragraph with the following:

	This more extensive verification testing required for primary function includes confirming that these functions are maintained:
	—	during in-use life;
	—	at end of shelf life;
	—	after transport simulation;
	—	at normal/anticipated conditions (see 10.2);
	—	after exposure to stressed/challenge conditions (see 10.3);
	as specified in the test matrix (see Table 3) unless justified by risk assessment (see 5.7.2).

H.1.1 Difference between the use of risk and harm

Replace the 2nd and 3rd paragraphs with the following:

The identification of essential performance considers both the severity of harm as well as the probability of occurrence of harm (including all mitigations implemented) when determining unacceptable risk.

The identification of primary function only considers the severity of harm when determining unacceptable harm.

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