ISO/TS 81060-5:2020 非侵襲的血圧計 — Part 5: 自動化された非侵襲的血圧計のテストのためのNIBPシミュレーターの再現性と再現性の要件 | ページ 2

Foreword

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This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical equipment.

A list of all parts in the ISO 81060 series and the IEC 81060 series can be found on the ISO website.

Introduction

The repeatability and reproducibility of NIBP simulators intended to test automated sphygmomanometers should be ensured, as they are often used to check the stability of an automated sphygmomanometer over time of use, after repair or to compare automated sphygmomanometers of the same type.

This document should be used to determine the quality of the NIBPsimulator once it is produced, sold or received by the responsibleorganization and thereafter periodically tested for the purpose of quality control. It specifies acceptance limits for repeatability and reproducibility regarding the amplitude and shape of the generated oscillations. Indirectly, it also tests the repeatability and reproducibility of the shape of the envelope of generated oscillations over (cuff) pressure, since the document specifies measurements at different static pressures at the same setting of the NIBPsimulator, thus measuring the envelope at 2 or 3 pressure values. If there are reasons to doubt that this number is too low, the test might be extended to 5 or more static pressures. It is not practically hard to do, to compare the whole envelope of the generated oscillations by a dynamic process, i.e. by recording the data during the deflation or inflation of the cuff. This kind of dynamic measurement would require an identical deflation or inflation curve. Technically, this can be done by a closed-loop process, which is not a simple task. Since the oscillations at constant pressures are not different from those during small pressure changes, the proposed approach is adequate.

The tests described in this document should be repeated periodically to ensure the long-term stability of the NIBP simulator.

In this document, it is intended to balance the tests necessary to ensure the stability of the NIBP simulator required to work properly and the effort to do it. Many of the recordings required can be evaluated under different aspects.

In this document, the following print types are used:

• requirements, conformance with which can be verified, and definitions: roman type;
• notes and examples: smaller roman type;
• defined terms and test methods: italic type;

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

For the purposes of this document, the auxiliary verb:

• “shall” means that conformance with a requirement or a test is mandatory for conformance with this document;
• “should” means that conformance with a requirement or a test is recommended but is not mandatory for conformance with this document;
• “may” is used to describe permission (e.g. a permissible way to achieve conformance with a requirement or test);
• "can" is used to describe a possibility or capability; and
• "must" is used to express an external constraint.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

1 Scope

This document specifies requirements for the repeatability and reproducibility of non-invasiveblood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.

In addition, the pulse rate set on the NIBP simulator is tested.

This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).

This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.

This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.

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.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14155:2011, ISO 81060-1:2007, IEC 60601-1:2005+AMD1:2012, IEC 60601-2-30:2018 and the following apply.

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

Bibliography