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醫(yī)療器械有效期驗證是非臨床驗證中的必要的一項，其基本要求來自于ISO 13485（YY/T 0287）中的“文件控制”和“記錄控制”：

......此期限應(yīng)確保至少在組織所規(guī)定的醫(yī)療器械壽命期內(nèi)，......

組織應(yīng)保存記錄的期限至少為組織所規(guī)定的或適用的法規(guī)要求所規(guī)定的醫(yī)療器械的壽命期, ......

對于有源醫(yī)療器械，尤其是設(shè)備類產(chǎn)品，預(yù)期使用壽命是制造商規(guī)定的預(yù)期保持產(chǎn)品安全和有效使用的時間段，根據(jù)風(fēng)險管理的要求，制造商需要評估整個使用壽命內(nèi)的風(fēng)險控制措施的有效性。

產(chǎn)品的穩(wěn)定性（可靠性，Stability / Reliability）將會影響產(chǎn)品的預(yù)期使用壽命?？煽啃钥梢酝ㄟ^測試或分析來進行確認。其中測試方法通常包括環(huán)境加速老化試驗，有源醫(yī)療器械使用期限注冊技術(shù)審查指導(dǎo)原則（2019年第23號）中對此進行了說明。此外還有高加速壽命測試（HALT）和高加速壓力篩選（HASS）等驗證方法?？煽啃缘姆治隹梢酝ㄟ^預(yù)期壽命分析來進行，考慮產(chǎn)品使用過程中的各種因素，NMPA的指導(dǎo)原則中也給出了相應(yīng)的需要考慮的因素和要求。同時還可以考慮參考相關(guān)的標(biāo)準(zhǔn)（風(fēng)險管理、電氣安全、軟件生命周期等）進行分析。

在預(yù)期壽命期間可能需要對產(chǎn)品進行維護、修理或升級。例如，對于醫(yī)療器械軟件（SaMD）來說，制造商需要持續(xù)進行上市后警戒以確保其產(chǎn)品的安全性，如在預(yù)期使用壽命內(nèi)提供安全更新。同時，由于軟件所運行操作系統(tǒng)的更新，比如微軟僅維護Win 10，Win 11，但不再維護Win 7之前的操作系統(tǒng)，此時，SaMD的制造商可能需要維護一個或兩個主要的軟件發(fā)布版本來持續(xù)提供預(yù)期使用壽命內(nèi)的更新或補丁。（但更新時需注意NMPA軟件指導(dǎo)原則中對于變更類型以及版本號的要求，重大變更、發(fā)布版本的變化需要進行許可事項變更注冊。而在歐美法規(guī)體系下，可能只需要將這些變更進行記錄或LTF以備查）

另外需要注意的是要區(qū)分預(yù)期使用壽命（Expected lifetime）和貨架有效期/保質(zhì)期（Shelf-life）。預(yù)期使用壽命是設(shè)備在無法達到預(yù)期用途之前的實際可持續(xù)使用時間，它的穩(wěn)定性應(yīng)該能夠承受使用過程中性能的退化，例如重復(fù)使用過程中的清潔和消毒處理。貨架有效期是指原包裝中的醫(yī)療器械或附件在制造商規(guī)定的條件下保持其穩(wěn)定性的期限，通常用于無菌包裝，它的有效期在打開包裝時，或制造商規(guī)定的保質(zhì)期到期時結(jié)束。

有源醫(yī)療器械的有效期驗證對于進口器械的制造商來說總是充滿了太多的困惑，為了便于向老外們解釋NMPA的要求，特地整理了一份英文版的概述性介紹，以便將來可以隨時甩給他們，各位也有同樣需求的同學(xué)拿走不謝。

1.     Guidelines Summary

1.1  Overview

The NMPA guidelines on Active Medical Device Expected Lifetime (NMPA Guideline 2019-23) provide detailed guidance on analyzing and verifying the device's expected lifetime. When analyzing the potential degraded characteristics of the device, the manufacturer should perform risk analysis and risk control measures.

The guidelines provide two ways for device expected lifetime evaluation:

Set the pre-defined expected lifetime by assessment or practical experiences and verify it through one or more methods.

Determine the expected lifetime through one or more methods.

There are two approaches to evaluate the expected lifetime:

Verify the whole system (product) directly through real-time aging or accelerated aging tests, considering the device usage requirements of frequency, intensity, and environment.

Break down the system (product) into different subsystems/components, identify the critical and non-critical parts, and then define or determine the expected lifetime.

The following factors need to be considered during expected lifetime evaluation:

Critical component(s): the manufacturer should consider the safety of the critical component(s), i.e., dielectric strength, resistance, mechanical strength, or battery power... will these performances degrade over time, are the mechanical actions between the critical components could cause the degradation of the intended use, or if the production process will impact the critical components long-term performance...

Usage frequency and intensity: the frequency can be cycle times of use or continuous working period. The intensity can be under normal conditions or extreme conditions, for example normal power/max power. The intensity can also be verified by extreme stress tests.

Transport, storage, and use environment: when evaluating the expected lifetime, it is also needed to consider extreme transportation, storage, and environmental conditions. However, through risk analysis, if these conditions do not impact the S&P of the device, this factor can be non-essential.

Cleaning and disinfection: the cleaning and disinfection procedures, as well as chemical residues may cause the degradation of the device, which need to be considered and assessed.

Packaging and sterilization: the sterilization procedures and methods/parameters need to be considered for their impacts to the expected lifetime.

Maintenance: the repairment, maintenance, and replacement of the parts need to be considered for the impacts to the expected lifetime.

Commercial: the marketing strategy, and after-service can also be the consideration for defining the lifetime of the device.

1.2  Assessment methods

1.2.1      Prospective research on device/critical parts through accelerated aging test, and/or verified by real-time aging test.1

1.2.2      Experience data analysis on the new device and predicate/equivalent device, including sample product testing, clinical use, repair rate or records, complaints history, literature, etc.

1.2.3      The reliability assessment on device/critical parts, simulation tests, or other simulated calculation methods

[1] Aging test for active device, refer to GB/T 34986-2017 Methods for product accelerated testing, identical to IEC 62506: 2013. For non-active device/parts or sterile package, refer to ASTM F1980