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ISO 20417:2021

ISO 20417:2026

修訂說明及影響

4 General considerations

b) Where this document specifies a specific edition of a normatively referenced document, the manufacturer may substitute a more current version provided the manufacturer can demonstrate that the residual risk that results from the substitution remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.

刪除

刪除了對(duì)于參考文件的最新版本要求

c) Information supplied by the manufacturer shall be in a language that is appropriate to the intended user.

b）             Information supplied by the manufacturer shall be in a language that:

1) is appropriate to the intended user;

2) conforms with the applicable policy.

增加了對(duì)于信息需要考慮適用法規(guī)的考量

5.2 Graphical information

a) Any graphical information that is replacing text such as pictograms, symbols, safety signs and safety related identification colours used in the information supplied by the manufacturer shall have the meaning explained in the accompanying documentation.

a) Unless the applicable policy does not require graphical information to be explained, any graphical

information that is replacing text such as pictograms, symbols, safety signs and safety-related

identification colours used in the information supplied by the manufacturer shall have the meaning

explained in the accompanying information.

明確了除非適用政策明確了無需解釋之外，所有的圖形信息都需要在手冊(cè)中解釋

5.3.1 Language identifiers

b) may be identified using: 1) the plain text name of the language; or  

2) the language codes given in 

i) ISO 639-1, 

ii) ISO 639-2, or 

iii) ISO 639-3[

b) In multilingual information supplied by the manufacturer, the language name used may be identified

using:

1) the plain text name of the language; or

2) the language codes in accordance with ISO 639 (see https:// standards .iso .org/ iso/ 639/ ed -2/ en/ ).

描述性變化，要求一致

5.6 Commercial product name

A medical device may be identified with a commercial product name specific to the medical device or the manufacturer. A commercial product name is used to assist in the identification of a medical device.

N/A

刪減了關(guān)于商業(yè)產(chǎn)品名稱的要求

5.10 Unique device identifier

a) Where necessary, a medical device or accessory shall be assigned a unique device identifier. 

b) This identifier shall have a 1:1 relation to: 

1) a single catalogue number; 

2) a single model number; or 

3) a single commercial product name

a) Unless the applicable policy does not require a unique device identifier, a medical device or accessory

shall be assigned a unique device identifier.

b) This identifier shall have a 1:1 relation to:

1) a single catalogue number; or

2) a single model number.

1）明確了除非有適用的政策規(guī)定可以不需要UDI，不然都需要有唯一標(biāo)識(shí)符；

2）刪除了對(duì)于單一產(chǎn)品名稱的唯一標(biāo)識(shí)符要求。

5.12 Sterile

a) A medical device or accessory that is sterile shall be identified as sterile. b) A sterile medical device or accessory shall be identified with the method of sterilization. c) Medical devices or accessories available sterile and non-sterile shall have different: 1) model numbers; or 2) catalogue numbers.

a) A sterile medical device or accessory shall be identified as sterile.

b) A sterile medical device or accessory shall be identified with the method of sterilization.

c) A sterile medical device or accessory shall be identified with the sterile barrier configuration.

d) Medical devices or accessories available in both sterile and non-sterile versions shall have different:

1) model numbers; or

2) catalogue numbers.

增加了無菌醫(yī)療器械或附件應(yīng)標(biāo)注其無菌屏障結(jié)構(gòu)的要求

6.1.1 Minimum requirements for the label

N/A

d) If the information required in 6.1 is not provided by marking, a justification for the omission shall be

documented in the risk management file.

增加了d）若第 6.1 條要求提供的信息未通過標(biāo)識(shí)予以提供，則應(yīng)在風(fēng)險(xiǎn)管理文件中記錄遺漏該信息的理由

6.1.2 Identificationof the manufacturer

d) Symbol 5.1.2 from ISO 15223-1:— may be used to identify the authorized representative. 1) When using symbol 5.1.2 from ISO 15223-1:—, the 'EC' may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1. 2) The address of the authorized representative may be applied by someone other than manufacturer.

d) Symbol 5.1.12 from ISO 15223-1:2021/Amd 1:2025 may be used to identify the authorized representative.

1) Where permitted by the applicable policy, the address of the authorized representative may be

applied by someone other than manufacturer.

對(duì)于授權(quán)代表直接引用ISO 15223-1的要求，不再單獨(dú)列出，要求一致。

6.1.3 Identification of the medical device or accessory

將要求重新按照不同的分類進(jìn)行了結(jié)構(gòu)重排，要求基本一致

6.1.4 Other label requirements

1）將要求重新按照不同的分類進(jìn)行了結(jié)構(gòu)重排，要求基本一致；2） 將滅菌類產(chǎn)品的標(biāo)識(shí)基于不同的標(biāo)識(shí)，進(jìn)行了不同要求

6.2 Identification requirements for detachable components of a medical device or accessory

刪除了產(chǎn)品名稱相關(guān)的條款

6.5.1 General information

結(jié)構(gòu)性變化，要求基本一致

6.5.3 Special conditions indicated on the packaging

2) Symbol 3869 from ISO 14617-2:2025 may be added adjacent to the symbols in 1) to indicate transport

environmental conditions.

3) Symbol 2066 from ISO 14617-2:2025 may be added adjacent to the symbols in 1) to indicate storage

environmental conditions.

新增ISO 14617-2:2025的符號(hào)可用于運(yùn)輸和儲(chǔ)存的環(huán)境要求

6.5.4 Sterile packaging

N/A

新增了關(guān)于滅菌包裝相關(guān)的要求

6.6.1 General

結(jié)構(gòu)性變化，要求一致

6.6.3 Additional requirements for the instructions for use for a lay user

結(jié)構(gòu)性變化，要求一致

6.6.4 Requirements for technical description

結(jié)構(gòu)性變化，要求一致

6.6.5 Requirements for e-documentation

e) If some or all of the accompanying information is provided as e-documentation, the manufacturer shall

determine whether access to some information should be restricted to a specific user group.

增加了對(duì)于特定的用戶組可以定義不同的電子版手冊(cè)的授權(quán)。

7.1 Importer

a) Where necessary, the label of a medical device or accessory shall include the name or trade name and full address of the importer to which the responsible organization can refer.  1) Symbol ISO 7000-3725 or symbol 5.1.8 from ISO 15223-1:— may be used to identify the importer. 2) The address of the importer may be applied by someone other than the manufacturer. i) An additional label shall not obscure any information on the label provided by the manufacturer. b) In locales where the importer is required to be registered, the address used shall be the same as the registered address.

a) Where the applicable policy requires the importer to be identified, the name or trade name and full

address of the importer to which the responsible organization can refer in accordance with the applicable

policy shall be included:

1) on the label; or

2) in the accompanying documentation.

b) Symbol ISO 7000-3725 or symbol 5.1.8 from ISO 15223-1:2021 may be used to identify the importer.

c) The address of the importer may be applied by someone other than the manufacturer.

) An additional label shall not obscure any information on the label provided by the manufacturer.

d) In locales where the importer is required to be registered, the address used shall be the same as the

registered address.

更明確了進(jìn)口商的相關(guān)信息