YY/T 0636.1-2021 PDF English
US$470.00 · In stock · Download in 9 secondsYY/T 0636.1-2021: Medical suction equipment - Part 1: Electrically powered suction equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0636.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0636.1-2021 | English | 470 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Medical suction equipment - Part 1: Electrically powered suction equipment
| Valid |
| YY 0636.1-2008 | English | 1079 |
Add to Cart
|
5 days
|
Medical suction equipment. Part 1: Electrically powered suction equipment. Safety requirements
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0636.1-2021
YY/T 0636.1-2021: Medical suction equipment - Part 1: Electrically powered suction equipment---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0636.1-2021
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.10
C 46
Replacing YY 0636.1-2008
Medical Suction Equipment - Part 1.Electrically Powered
Suction Equipment
(ISO 10079-1.2015, MOD)
Issued on. MARCH 9, 2021
Implemented on. MAY 1, 2023
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
1 Scope... 8
2 Normative References... 8
3 Terms and Definitions... 10
4 General Requirements... 12
4.1 Risk Management... 12
4.2 Usability... 13
4.3 Clinical Investigation... 13
4.4 Biophysical or Modeling Research... 14
4.5 General Electrical Safety... 14
4.6 Test Methods... 14
5 Cleaning, Disinfection and Sterilization... 14
6 Design Requirements... 14
6.1 Collection Container... 14
6.2 Connections... 15
6.3 Suction Tubing... 16
6.4 Vacuum Level Indicators... 16
6.5 Spillage on Electrically Powered Suction Equipment... 17
7 Operational Requirements... 17
7.1 Ease of Operation... 17
7.2 Dismantling and Reassembly... 17
7.3 Mechanical Shock... 17
7.4 Stability... 18
7.5 Protective Devices... 18
7.6 Noise... 19
7.7 Air Leakage... 19
8 Physical Requirements for Suction Equipment for Field Use... 20
8.1 * Dimensions... 20
8.2 Mass... 20
9 Performance Requirements for Vacuum Level and Flowrate... 20
9.1 High Vacuum / High Flowrate Equipment... 20
9.2 Medium Vacuum Equipment... 20
9.3 Low Vacuum / Low Flowrate Equipment... 21
9.4 Low Vacuum / High Flowrate Equipment... 21
9.5 Thoracic Drainage Equipment for Adults... 21
9.6 Intermittent Vacuum Equipment... 21
9.7 Vacuum Regulators with Fixed Setting... 22
9.8 Vacuum Regulators with Variable Setting... 22
9.9 Equipment Intended for Pharyngeal Suction... 22
9.10 Battery Powered Transportable Suction Equipment... 22
9.11 Interruption of Power Supply... 22
10 * Environmental Tolerance of Suction Equipment for Field and / or Transport Use
... 23
10.1 Operating Conditions... 23
10.2 Storage... 23
11 Information Provided by the Manufacturer (labeling and instructions for use)... 23
11.1 Use of Symbols... 23
11.2 Equipment Labeling... 23
11.3 Instructions for Use... 25
Appendix A (normative) Test Methods... 27
Appendix B (informative) Rationale Statement... 39
Appendix C (informative) Lumen Size and Its Effect on Flowrate... 40
Appendix D (informative) Schematic Diagram of Suction Equipment... 41
Bibliography... 42
Foreword
The series standard Medical Suction Equipment is divided into three parts.
---Part 1.Electrically Powered Suction Equipment;
---Part 2.Manually Powered Suction Equipment;
---Part 3.Suction Equipment Powered from a Vacuum or Positive Pressure Gas Source.
This is Part 1.
This Part was drafted in accordance with the rules provided in GB/T 1.1-2009.
This Part serves as a replacement of YY 0636.1-2008 Medical Suction Equipment - Part 1.
Electrically Powered Suction Equipment - Safety Requirements. In comparison with YY
0636.1-2008, apart from editorial modifications, the main technical changes are as follows.
---Some chapters and clauses based on GB 9706.1 are deleted; the structure of the standard
is adjusted.
---The requirements for “Scope” are modified; the description of the relations between YY
0636.1 and GB 9706.1 is deleted; “Figure 1 -- Schematic Diagram of Suction
Equipment” is moved to Appendix D; equipment inapplicable to this Part is deleted
(see Chapter 1 and Appendix D; Chapter 1 of Version 2008);
---“Normative References” is modified (see Chapter 2; Chapter 2 of Version 2008);
---Some terms and definitions are added, modified and deleted (see Chapter 3; Chapter 3
of Version 2008);
---The requirements for “general requirements” are added (see Chapter 4);
---The requirements for “spillage on electrical suction equipment” are added (see 6.5);
---The requirements for “ease of operation” are added (see 7.1);
---The requirements and test methods for “low vacuum / high flowrate equipment” are
added (see 9.4 and A.10);
---The requirements and test methods for “intermittent vacuum equipment” are added (see
9.6 and A.12);
---The requirements and test methods for “vacuum regulators with fixed setting” are added
(see 9.7 and A.13);
---The requirements and test methods for “vacuum regulators with variable setting” are
added (see 9.8 and A.14);
---The appendixes of “test methods” and “rationale statement” are added (see Appendix A
and Appendix B);
---The requirements for “labeling of equipment” and “instructions for use” are modified
(see 11.2 and 11.3; Chapter 6 of Version 2008);
---The requirements for “stability” are modified (see 7.4; 10.4 of Version 2008);
---The requirements for “vacuum level indicators” are modified (see 6.4; 56.8 in 16.3 of
Version 2008);
---The requirements for “inlet port” are modified (see 6.2.2; 56.12 in 16.3 of Version 2008);
---The requirements and test methods for “high vacuum / high flowrate equipment” are
modified (see 9.1 and A.9; 59.5 in 16.6 of Version 2008);
---The requirements and test methods for “medium vacuum equipment” are modified (see
9.2 and A.9; 59.6 in 16.6 of Version 2008);
---The requirements for “collection container” are modified (see 6.1 and A.2; 59.11 in 16.6
of Version 2008);
---The requirements for “thoracic drainage equipment for adults” are modified (see 9.5;
59.8 in 16.6 of Version 2008);
---“over-temperature”, “fire protection”, “pressure vessel and pressurized parts”,
“electrostatic charge”, “material of applied parts in contact with patient’s body”,
“accuracy of working data and prevention of hazardous output” and “abnormal
operational and fault condition. environmental tests” are deleted (see Chapter 13 ~
Chapter 15 of Version 2008);
---Appendix A ~ Appendix L, Appendix N and Appendix P, which are based on GB 9706.1,
are deleted (see Appendix A ~ Appendix L, Appendix N and Appendix P of Version
2008).
This Part adopts the re-drafting method in the modification and adoption of international
standard ISO 10079-1.2015 + AMD1.2018 Medical Suction Equipment - Part 1.Electrically
Powered Suction Equipment.
In comparison with ISO 10079-1.2015 + AMD1.2018, the main differences are as follows.
---In terms of Normative References, this Part makes adjustments with technical
differences to adapt to the technical conditions of China. The adjustments are
intensively reflected in Chapter 2 “Normative References”. See the specific
adjustments below.
GB/T 3767, which equivalently adopts international standard, is used to replace
ISO 3744 (see A.7);
GB/T 3785.1, which equivalently adopts international standard, is used to replace
IEC 61672-1 (see A.7);
GB/T 4208, which equivalently adopts international standard, is used to replace
IEC 60529 (see 6.5);
GB 9706.1-2020, which modifies and adopts international standard, is used to
replace IEC 60601-1.2005 + A1.2012 (see Chapter 4 and 6.5);
GB/T 16273.1, which non-equivalently adopts international standard, is used to
replace ISO 7000 (see 11.1);
YY/T 0297, which equivalently adopts international standard, is used to replace
ISO 14155 (see 4.3);
YY/T 0316, which equivalently adopts international standard, is used to replace
ISO 14971 (see 4.1.2);
YY/T 0466.1, which equivalently adopts international standard, is used to replace
ISO 15223-1 (see 11.1);
YY/T 1040.1, which equivalently adopts international standard, is used to replace
ISO 5356-1 (see 6.2.2);
YY/T 1474, which equivalently adopts international standard, is used to replace
IEC 62366 (see 4.2);
YY/T 9706.106, which modifies and adopts international standard, is used to
replace IEC 60601-1-6.2010 (see 4.2);
YY 9706.111-2021, which modifies and adopts international standard, is used to
replace IEC 60601-1-11.2010 (see 6.5);
YY 9706.112-2021, which modifies and adopts international standard, is used to
replace IEC 60601-1-12.2014 (see 6.5).
In comparison with ISO 10079-1.2015 + AMD1.2018, this Part makes the following editorial
modifications.
---The suspended paragraph before 4.1 is adjusted into “general electrical safety” (see 4.5);
---The editorial error in 9.6 is modified; the “deviation” of vacuum level and the “deviation”
of frequency are added (see 9.6);
---11.1 and 11.2 are combined into “use of symbols” (see 11.1);
---“if applicable” is added [see 11.2 a)];
---“or equivalent mark” is added [see 11.2 c)];
---The restricting requirement of “prefixed with ‘LOT’” is deleted [see 11.2 d)];
---The editorial error is modified; in accordance with the requirements of 6.1.3, “vacuum
level does not exceed 95 kPa” is modified into “vacuum level 95 kPa” (see A.3);
---The editorial error is modified; in accordance with the requirements of 6.3.1, “A > 0.5”
is modified into “A 0.5” (see A.4);
---The editorial error is modified; in accordance with the requirements of 7.5.3.2, “vacuum
source” is modified into “positive pressure source” (see A.6);
---The editorial error in Figure A.8 is modified; “45 kPa to 85 kPa” is modified into “50
kPa to 90 kPa” (see A.14).
Please be noted that certain content of this document might involve patents. The institution
issuing this document shall not undertake the responsibility of identifying these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee 116 on Anesthetic
and Respiratory Equipment of Standardization Administration of China (SAC/TC 116).
The drafting organizations of this Part. Shanghai Baojia Medical Equipment Co., Ltd.;
Shanghai Testing & Inspection Institute for Medical Devices; Shanghai University of Medicine
& Health Sciences.
The main drafters of this Part. Li Guihua, Yu Hongyi, Hu Zhaoyan, Zhang Yanfeng, Wang Wei,
Shao Guoliang, Yang Xiaoqing, Fu Guoqing.
The issuing of the previous versions.
---GB 5396-1985, GB 5397-1985, ZBC 46002-1985;
---YY 0099-1993, YY 0100-1993;
---YY 0636.1-2008.
Medical Suction Equipment - Part 1.Electrically Powered
Suction Equipment
1 Scope
This Part of YY/T 0636 specifies the safety and performance requirements for electrically
powered medical and surgical suction equipment.
This Part applies to equipment used for healthcare facilities, for example, hospitals, as well as
patients’ homecare, and in the field and transport.
2 Normative References
The following documents are indispensable to the application of this document. In terms of
references with a specified date, only versions with a specified date are applicable to this
document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this document.
3 Terms and Definitions
The following terms and definitions are applicable to this document.
Free air flowrate refers to unrestricted airflow through a designated inlet port.
Low flowrate refers to a free air flowrate (3.7) smaller than 20 L/min.
4 General Requirements
In accordance with YY/T 9706.106 and YY/T 1474, the manufacturer shall describe the
usability engineering process and the risks associated with poor usability.
If the same level of safety is obtained, the manufacturer may use a different type test than the
type described in this Part. Alternative test methods shall be validated in accordance with the
test method specified in Appendix A.
5 Cleaning, Disinfection and Sterilization
Where applicable, parts of the suction equipment that may be contaminated shall be disposable,
or be cleaned, disinfected or sterilized. These parts include filters, suction tubing and collection
containers.
6 Design Requirements
If applicable, at 120% of the maximum vacuum level recommended by the manufacturer or 95
kPa below the atmospheric pressure (whichever is smaller), after 5 min, the collection container
shall not implode, rupture or permanently deform, and shall comply with the requirements of
Chapter 7 and Chapter 9.
7 Operational Requirements
If the suction equipment can be operated outside its carrying case, the various parts of the
suction equipment shall be subject to the drop test and reassembled in accordance with the
above-mentioned requirements. If applicable, the reassembled suction equipment shall comply
with the relevant requirements of Chapter 9.
8 Physical Requirements for Suction Equipment for Field Use
The mass of the suction equipment intended for field use, including its carrying case or stand,
and accessories, shall not exceed 6 kg.
9 Performance Requirements for Vacuum Level and Flowrate
The suction equipment marked with “low vacuum / low flowrate” shall generate a vacuum level
of not greater than 20 kPa. When being set at the maximum vacuum level recommended by the
manufacturer, the continuous free air flowrate shall be less than 20 L/min.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 0636.1-2021 be delivered?Answer: The full copy PDF of English version of YY/T 0636.1-2021 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 0636.1-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0636.1-2021_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0636.1-2021 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version YY/T 0636.1-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0636.1-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of YY/T 0636.1-2021?A step-by-step guide to download PDF of YY/T 0636.1-2021_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0636.1-2021".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|