YY/T 0636.2-2021Medical suction equipment - Part 2: Manually powered suction equipment (English PDF)
医用吸引设备 第2部分：人工驱动吸引设备
This is a limited preview
Buy now to download the full PDF (23 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0636.2-2021 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 0636.2-2021 is the English-translated version of 医用吸引设备 第2部分：人工驱动吸引设备.
YY/T 0636.2-2021 is the Chinese standard "Medical suction equipment - Part 2: Manually powered suction equipment". Its scope clause reads: This part of YY/T 0636 specifies the safety and performance requirements of manually driven suction equipment used for pharynx suction.
This part of YY/T 0636 applies to equipment that is operated by foot pedal, manual operation or both. Appendix A provides an example of a typical system The figure illustrates the three parts of YY/T 0636.
Artificially driven suction equipment is usually used outside of medical and health care institutions, and is often described as field use or transportation use.
Use in these situations may involve extreme weather or terrain conditions. YY/T 0636 This part also includes Additional requirements for the suction equipment for the loss.
This part of YY/T 0636 does not apply to the following content. a) Suction catheter, Yankee suction tube and suction head and other end pieces; b) Dental suction equipment; c) Mucus extractor, including neonatal mucus extractor. Its clauses include terms and definitions.
Found what you need?
Document preview — YY/T 0636.2-2021
National Standard of the People's Republic of China
- Classification
- C 46
- Replacing
- YY 0636.2-2008
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 4.1 Risk Management
- 4.2 Availability
- 4.3 Clinical investigation
- 4.4 Biophysics or model research
- 5 Cleaning, disinfection and sterilization
- 6 Design requirements
- 6.1 Collection container
- 6.2 Connection
- 6.3 Attraction pipeline
- 6.4 Negative pressure indicator
- 7 Operation requirements
- 7.1 Easy to operate
- 7.2 Disassembly and reassembly
- 7.3 Mechanical shock
- 7.4 Stability
- 7.5 Guard
- 7.6 Soaking
- 8 Physical requirements for attraction equipment used in the field and transport
- 8.1 *Size
- 8.2 Quality
- 9 Performance requirements for negative pressure value and flow rate
- 9.1 Negative pressure
- 9.2 Free air flow
- 9.3 Pharyngeal suction
- 10 *Environmental tolerance of suction equipment used in the field and/or transport
- 10.1 Working conditions
- 10.2 Storage
- 11 Mark
- 11.1 Use of symbols
- 11.2 Equipment
- 11.3 Equipment or carrying case
- 12 Information provided by the manufacturer
- Appendix A (informative appendix) Schematic diagram of suction equipment
- Appendix B (Normative Appendix) Test Method
- Appendix C (informative appendix) Basic principles
- Appendix D (informative appendix) Lumen size and its effect on flow
1 Scope
This part of YY/T 0636 specifies the safety and performance requirements of manually driven suction equipment used for pharynx suction.
This part of YY/T 0636 applies to equipment that is operated by foot pedal, manual operation or both. Appendix A provides an example of a typical system
The figure illustrates the three parts of YY/T 0636.
Artificially driven suction equipment is usually used outside of medical and health care institutions, and is often described as field use or transportation use.
Use in these situations may involve extreme weather or terrain conditions. YY/T 0636 This part also includes
Additional requirements for the suction equipment for the loss.
This part of YY/T 0636 does not apply to the following content.
a) Suction catheter, Yankee suction tube and suction head and other end pieces;
b) Dental suction equipment;
c) Mucus extractor, including neonatal mucus extractor.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 16273.1 Graphical symbols for equipment Part 1.General symbols (GB/T 16273.1-2008, ISO 7000..2004,
NEQ)
YY/T 0297 Clinical Investigation of Medical Devices (YY/T 0297-1997, ISO 14155.1996, IDT)
YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007, IDT)
YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements (YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 1040.1 Cone joints for anesthesia and respiratory equipment Part 1.Cone head and cone sleeve (YY/T 1040.1-2015,
ISO 5356-1.2004, IDT)
YY/T 1474 Application of medical device usability engineering to medical devices (YY/T 1474-2016, IEC 62366.2007,
IDT)
ISO 80369 (all parts) Small bore connectors for medical liquids and gases (Smal-boreconnectorsforliquidsand gasesinhealthcareapplications)
EN1041 Information provided by the manufacturer of medical devices (Informationsuppliedbythemanufacturerofmedicalde- vices)
3 Terms and definitions
The following terms and definitions apply to this document.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16273.1Graphical symbols for use on equipment -- Part 1: Common symbols
- YY/T 0297General requirements for clinical investigation of medical devices
- YY/T 0316Medical devices-Application of risk management to medical devices
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY/T 1040.1Anaesthetic and respiratory equipment—Conical connectors - Part 1: Cones and sockets
- YY/T 1474Medical devices - Application of usability engineering to medical devices
ISO 5356-1:2004 · ISO 80369 · EN 1041
Similar standards
Editions of YY/T 0636.2
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0636.2-2021 | Medical suction equipment - Part 2: Manually powered suction equipment | current edition | Current |
| YY 0636.2-2008 | Medical suction equipment - Part 2: Manually powered suction equipment | previous edition | Superseded |
This page sells the current edition, YY/T 0636.2-2021. Earlier editions are listed for reference only.
How to Download YY/T 0636.2-2021
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 16273.1-2008 — Graphical symbols for use on equipment -- Part 1: Common symbols
YY/T 0297-1997 — Clinical investigation of medical devices
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 0636.2-2021
$300.00