GB 9706.218-2021Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment (English PDF)

201.4 of this document, Clause 3 of the 2000 edition);

- AMEND "General requirements for testing" to "General requirements for testing

of ME EQUIPMENT"; ADD "TYPE TESTS" and "Humidity preconditioning

treatment" (see 201.5 of this document, Clause 4 of the 2000 edition);

- AMEND "Classification" to "Classification of ME EQUIPMENT and ME

SYSTEMS"; ADD "Protection against electric shock" (see 201.6 of this document,

Clause 5 of the 2000 edition);

- AMEND "Identification, marking and documents" to "ME EQUIPMENT

identification, marking and documents"; AMEND "Marking on the outside of ME

EQUIPMENT or ME EQUIPMENT parts" and "ACCOMPANYING

DOCUMENTS"; ADD "Marking of controls and instruments", "Symbols" (see

201.7 of this document, Clause 6 of the 2000 edition);

- ADD "Classification of APPLIED PARTS", "Separation of parts"; AMEND

"Insulation", "CREEPAGE DISTANCES and AIR CLEARANCES" (see 201.8 of

this document);

- AMEND "HAZARDS associated with moving parts", "Expelled parts HAZARD";

ADD "HAZARDS associated with surfaces, corners and edges", "Instability

HAZARDS", "Pressure vessels and parts subject to pneumatic and hydraulic

pressure", "HAZARDS associated with support systems" (see 201.9 of this

document, Section IV of the 2000 edition);

- ADD "Lasers and light emitting diodes (LEDs)", "Other visible electromagnetic

radiation", "Infrared radiation", "Ultraviolet radiation" (see 201.10 of this

document);

- ADD "Thermal and other HAZARDS from INTERCONNECTION

CONDITIONS with LASERS"; AMEND "APPLIED PARTS not intended to

supply heat to a PATIENT", "GUARDS", "Ingress of water or particulate matter

into ME EQUIPMENT and ME SYSTEMS", "Thermal and other HAZARDS from

INTERCONNECTION CONDITIONS with HF SURGICAL EQUIPMENT" (see

201.11 of this document);

- ADD "USABILITY", "Alarm systems", "Protection against hazardous output" (see

201.12 of this document);

- ADD "Image observation" (see 201.13 of this document);

- ADD "PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)" (see

201.14 of this document);

- ADD "Construction of connectors"; AMEND "General", "Rough handling test"

(see 201.15 of this document);

- ADD "ME SYSTEMS" (see 201.16 of this document);

- AMEND "Electromagnetic compatibility of ME EQUIPMENT and ME

SYSTEMS", "Electromagnetic compatibility - Requirements and tests" (see

201.17 and Clause 202 of this document, Clause 36 of the 2000 edition).

This document uses the redrafting method to amend and adopt IEC 60601-2-18.2009

"Medical electrical equipment - Part 2-18.Particular requirements for the basic safety

and essential performance of endoscopic equipment".

The technical differences between this document and IEC 60601-2-18.2009 and their

reasons are as follows.

- Regarding normative references, this document has made adjustments with

technical differences to adapt to the technical conditions of China. The adjustments

are concentrated in 201.2 "Normative references", and the specific adjustments are

as follows.

- REPLACE IEC 60601-1-2.2007 with YY 9706.102, which is modified from the

international standard (see Clause 202);

- REPLACE IEC 60601-2-2.2017 with GB 9706.202, which is modified from the

international standard (see 201.7.9.2.14, 201.11.101.2);

- REPLACE IEC 60601-2-37 with GB 9706.237, which is modified from the

international standard (see 201.4.1.102).

- DELETE 201.7.9.2.12 Cleaning, disinfection and sterilization, to adapt to the

technical conditions of China.

The following editorial changes have been made to this document.

- AMEND the informative Annex BB;

- Replace the international documents in the bibliography with the corresponding

Chinese documents, as follows.

- REPLACE ISO 594 with GB/T 1962 (all parts), which is identical to the

international standard;

- REPLACE ISO 14971 with YY/T 0316, which is identical to the international

standard;

- REPLACE IEC 60601-1-8 with YY 9706.108, which is modified from the

international standard.

- DELETE the index of defined terms of the international standard.

Attention is drawn to the possibility that some of the elements of this document may be

the subject of patent rights. The issuing authority shall not be held responsible for

identifying any or all such patent rights.

This document was proposed and shall be under the jurisdiction of the National Medical

Products Administration.

The previous released versions replaced by this document are as follows.

- It is first published in 2000 as GB 9706.19-2000;

- This is the first revision.

201.1 Scope, object and related standards

Clause 1 of the general standard applies, except as follows.

201.2 Normative references

The following referenced documents are indispensable for the application of this

document.

201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in the general

standard apply, except as follows.

201.4 General requirements

Clause 4 of the general standard applies, except as follows.

201.5 General requirements for testing of ME EQUIPMENT

Clause 5 of the general standard applies, except as follows.

201.6 Classification of ME EQUIPMENT and ME SYSTEMS

Clause 6 of the general standard applies, except as follows.

201.7 ME EQUIPMENT identification, marking and documents

Clause 7 of the general standard applies, except as follows.

201.8 Protection against electrical HAZARDS from ME EQUIPMENT

Clause 8 of the general standard applies, except as follows.

201.9 Protection against MECHANICAL HAZARDS of ME

EQUIPMENT and ME SYSTEMS

Clause 9 of the general standard applies, except as follows.

201.10 Protection against unwanted and excessive radiation HAZARDS

Clause 10 of the general standard applies, except as follows.

201.11 Protection against excessive temperatures and other HAZARDS

Clause 11 of the general standard applies, except as follows.

201.12 Accuracy of controls and instruments and protection against hazardous outputs

Clause 12 of the general standard applies, except as follows.

201.15 Construction of ME EQUIPMENT

Clause 13 [Translator note. should be Clause 15] of the general standard applies, except

as follows.

201.16 ME SYSTEMS

Clause 16 of the general standard applies.

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

Clause 17 of the general standard applies.

202 Electromagnetic compatibility - Requirements and tests YY 9706.102 applies, except as follows.

202.6.2 IMMUNITY

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