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GB 9706.39-2008 English PDF

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GB 9706.39-2008: Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
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GB 9706.39-2008English394 Add to Cart 3 days [Need to translate] Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment Obsolete GB 9706.39-2008

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Standard similar to GB 9706.39-2008

GB/T 39381.1   YY/T 1680   YY/T 1571   GB 9706.255   GB 9706.271   GB 9706.222   

Basic data

Standard ID GB 9706.39-2008 (GB9706.39-2008)
Description (Translated English) Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
Sector / Industry National Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.20
Word Count Estimation 10,185
Date of Issue 2008-12-31
Date of Implementation 2010-02-01
Adopted Standard IEC 60601-2-3-2003, IDT
Regulation (derived from) Announcement of Newly Approved National Standards No. 23 of 2008 (No. 136 overall)
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This Chinese standard specifies the peritoneal dialysis dedicated device (see 2. 1. 102 defined hereinafter equipment) the minimum safety requirements. This standard applies to the use or intended for medical personnel under the supervision of medical specialists in the use of equipment, including use in hospitals or in the home environment using equipment operated by the patient. This requirement does not apply to special dialysate dialysate lines and plans only for continuous ambulatory peritoneal dialysis equipment.

GB 9706.39-2008: Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment


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Medical electrical equipment.Part 2-39. Particular requirements for the safety of peritoneal dialysis equipment ICS 11.040.20 C45 National Standards of People's Republic of China GB 9706.39-2008/IEC 60601-2-39.2003 Medical Electrical Equipment Part 2-39. Peritoneal Dialysis Requirements for safety equipment (IEC 60601-2-39.2003, IDT) Published 2008-12-31 2010-02-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued

Foreword

All technical contents of this standard is mandatory. "Medical electrical equipment" consists of two parts. --- Part 1. General requirements for safety; --- part 2. requirements for the safety. This standard is part of the safety requirements for 2-39 peritoneal dialysis apparatus. Equivalent standards adopted international standard 60601-2-39 IEC .2003 "Medical Electrical Equipment Part 2-39. Security peritoneal dialysis apparatus Full-specific requirements. " For ease of use, to IEC 60601-2-39.2003, this standard made the following editorial changes. --- delete IEC 60601-2-39 cover and foreword; --- auxiliary verbs translation of this standard is consistent with GB 9706.1. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee on Medical Appliances (SAC/TC10), the national medical cardiopulmonary bypass equipment Standardization Technical Committee Will (SAC/TC158) centralized. This standard was drafted. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center for Drug Evaluation Guangdong Certification Center, Chongqing Science and Technology Co., Ltd. Shan Shan. The main drafters. Chen Yuen, Ye Chen Jia, Yan Lin, Zhang Yang, Zēng Fanfeng, Yang Guang, Yong high light. GB 9706.39-2008/IEC 60601-2-39.2003 Medical Electrical Equipment Part 2-39. Peritoneal Dialysis Requirements for safety equipment The first chapter outlines Except as follows, "common standards" Benpian chapter shall apply. Scope 1 and object Except as follows, "General Standard" Chapter applies. 1.1 Scope increase. This standard specifies the special peritoneal dialysis equipment (see 2.1.102 defined hereinafter referred to as equipment) the minimum security requirements. This standard applies to the proposed For medical personnel or equipment used under the supervision of medical specialists, including in hospitals or operated by the patient in the home environment device of. This requirement does not apply special dialysate, the dialysate lines and programs only for continuous ambulatory peritoneal dialysis apparatus. 1.2 Purpose instead. This object specific standard equipment 2.1.102 defined requirements for the safety of its provision. 1.3 Specific Standard increase. This specific standard by the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (IEC 60601-1. 1988, IDT amendments and No. 1.1991, No. 2 amendments.1995); GB 9706.15-2008 (IEC 60601-1-1.2000, IDT No. 1 second amendments.1995); YY0505-2005 (IEC 60601-1-2.2001, IDT) and IEC 60601-1-4.1996 constituting a Group IEC publication has been modified and supplemented. In this specific standard, GB 9706.1-2007/IEC 60601-1. 1988 is referred to as the "General Standard" or "General Requirements", and GB 9706.15-2008/IEC 60601-1-1.2000, YY0505-2005/IEC 60601-1-2.2001 and IEC 60601-1-4 were Called "collateral standard." The term "present standard" includes this specific standard and other standards used in parallel with the universal standard. This specific standard chapter number corresponding to the chapter number common standard. Changes to the text of the common standards, require the use of the following words He says. "Instead of" --- terms and conditions for common standards has been completely replaced this specific standard text. "Increase" --- indicates that this specific standard text is added to the General Standard requirements. "Modify" General terms --- represents a standard has been modified, as shown in this specific standard text. General Standard clauses or numerals in FIG increased, starting from 101, additional annexes to AA, BB and other markers; column item is increased In aa), bb) and other markers. If the present standard no corresponding dedicated chapter, the chapter is used as it is common standard. If the General Standard, although some of the content-related, but does not apply to used, is described in this exclusive standard. Instead of the standard or common standard amendment request, priority to the initial requirements. GB 9706.39-2008/IEC 60601-2-39.2003

2 Terms and Definitions

Except as follows, "General Standard" Benpian pieces apply. 2.1.5 instead. Drawn from the dialysate equipment delivered to the patient's abdominal cavity, and then the line leading to the dialysate drain bag or a drain pipe, and all The fixing member has a conductive connection, it should be considered as part of the application. Increase definitions. 2.1.101 The dialysate is introduced into a patient's abdominal cavity, and then the process then it is discharged. 2.1.102 It is used in peritoneal dialysis apparatus. 2.1.103 The relevant pharmacopoeia monographs preparation, pharmaceutical formulations (solutions) for use with the device. 2.1.104 Poured dialysate (FIL) phase of the abdominal cavity. Note. The term "fil" is generally used as "inflow" synonymous. 2.1.105 A shunt (Drain) stage dialysate. Note. The term "drain" is generally used as "outflow" synonymous. 2.1.106 To protect the security risk to the patient from possible specially designed automated system can detect the specific parameters or the structural characteristics.

3 General requirements

Except as follows, "General Standard" Benpian pieces apply. 3.6 Addition. aa) any protective system failure. General requirements Test 4 Except as follows, "General Standard" Benpian pieces apply. 4.6 Other conditions increase. If the detection result of the initial temperature will affect the dialysate, the dialysate temperature at the start of the test should be less than 4 ℃, or to achieve Minimum temperature specified by the manufacturer. 6 to identify, mark and file Except as follows, "General Standard" Benpian pieces apply. GB 9706.39-2008/IEC 60601-2-39.2003 6.8.1 Overview increase. Random file should also include. --- noted that in order to avoid siphoning regurgitation when open drainage channel, with the line between the dialysate outlet tube should be left between the air The importance of the gap. 6.8.2 Manual increase. aa) instructions for use should also include the following. 1) the description, serve to achieve the necessary level of disinfection or sterilization process; 2) If necessary, provides a proven disinfection or sterilization effectiveness test procedure declaration; 3) The operator should pay attention to the risk of security-related instructions when connecting or disconnecting the patient; 4) explain the measures should take any protective action when the alarm system; 5) a list and connecting the dialysate line recommended for use with the device; 6) a statement of electromagnetic radiation may result in safety hazards, which may affect the safe operation of equipment. The statement should Include include a representative, possible example of a device of this radiation, the home environment should also be considered possible The presence of; 7) Description when using Class I devices, the reliability of the importance of the ground during the installation of protection; 8) should be described using one kind of equipotential conductor; 9) Description is to be noted misassembly operator, misconnection dialysate line may cause safety hazard; 10) explained the owner/operator to pay attention to the dialysate choose incorrectly, it may cause safety hazard. By checks to verify compliance. 6.8.3 SHEET increase. aa) should include the following technical specifications. 1) When using the device to install or start, specialized testing needs to be performed or observed, including the type of test to be carried out and Guide number; 2) type of protection system requirements and accuracy 51.101; 3) 51.101b) requires an acoustic alarm may be delayed in time; 4) the audible alarm silence period; 5) the sound pressure level of the alarm sound is adjustable to any range; 6) for the maximum positive and poured dialysate (or) the patient's abdominal cavity pump discharge, and can produce (or) negative; 7) Method and sensitivity 51.103 meet the requirements of the protective system used; 8) The method meet the requirements of 51.104 protection system employed and the sensitivity. By checks to verify compliance. The second environmental conditions "Common Criteria" Benpian chapter shall apply. Title III protection against electric shock hazard Except as follows, "common standards" Benpian chapter shall apply. 19 Continuous leakage currents and patient auxiliary current Except as follows, "General Standard" in this section applies. GB 9706.39-2008/IEC 60601-2-39.2003 19.4 Test h) measuring the leakage current of the patient increase. 12) measuring the leakage current at the connection point should be patient dialysate line and a peritoneal catheter. During the test, dialysate flow through the dialysate tube should road. Equipment provided should be fully configured in accordance with the intended use declared by the manufacturer. Title IV of protection against mechanical hazards "Common Criteria" Benpian chapter shall apply. The fifth chapter of unnecessary or excessive radiation hazard protection "Common Criteria" Benpian chapter shall apply. Title VI of the risk protection ignite flammable anesthetic gases mixed "Common Criteria" Benpian chapter shall apply. Title VII of the ultra-mild other security risk protection Except as follows, "common standards" Benpian chapter shall apply. Overflow 44, liquid spill, leak, moisture, into the liquid, cleaning, sterilization, disinfection and compatibility Except as follows, "General Standard" in this section applies. 44.1 Overview increase. 44.2 to 44.4 should be used dialysate. 44.3 liquid spill instead. Equipment should be designed to occur if the liquid spill will not cause safety hazard. By the following test to verify compliance requirements. Apparatus in a normal use position, the top surface of the device to the dialysate 3L inverted for pouring time of the liquid should be greater than 15s. Examination immediately after the test should indicate that there is likely to enter into the dialysis fluid inside the device does not get wet may cause a security risk Member insurance. When in doubt, conduct a dielectric strength test under the "General Standard" Chapter 20, the device should be able to work properly. 44.6 inlet increase. Equipment shall be designed so that when it is placed in the normal position of use, or if the storage tank leak dialysate line is not generated security Dangerous area. By the following test to verify compliance requirements. Each member with a pipette to the dialysis liquid droplets may be adversely affected on. Examination immediately after the test should indicate that there is likely to enter into the dialysis fluid inside the device does not get wet may cause a security risk Member insurance. If in doubt, the equipment should be a dielectric strength test under the "General Standard" in Chapter 20. The accuracy and prevent the risk of data output from the eighth chapter of the work Except as follows, "common standards" Benpian chapter shall apply. 51 to prevent the danger output Except as follows, "General Standard" in this section applies. GB 9706.39-2008/IEC 60601-2-39.2003 increase. 51.101 dialysate temperature a) If the apparatus includes a dialysate heating means, the device should be equipped with an independent temperature control system of any anti Protection system to prevent the application part dialysate measured patient end temperature exceeds 41 ℃. b) operation of the protection system should implement the following safety conditions. --- stopping the flow of dialysis fluid to a patient; --- trigger the alarm sound and light. Note. The audible alarm may be suitable delay specified by the manufacturer. By measuring the dialysate patient end portion at the application temperature, to verify compliance. The test shall be in the most adverse conditions infusion Under carried out. 51.102 Pressure If the apparatus comprises a specifically provided to assist the patient's abdominal cavity to the dialysate inlet of the pump, the pump should be able to prevent more than specified by the manufacturer Given maximum pressure. If the apparatus comprises a specifically provided to assist the patient has used the dialysate discharging pump, the pump should be capable of producing more than prevent The maximum negative pressure specified provider. Note. The overvoltage may cause damage to the peritoneum. After a review of random files and functional testing to verify compliance. 51.103 air into a) If the apparatus comprises a specifically provided to assist the patient's abdominal cavity to the dialysate inlet of the pump, the equipment should be provided for preventing a blank Gas is pumped into the abdominal cavity caused by dangerous safety protection system. Note. a small amount of air, e.g. dialysate individual bubbles are not considered safety hazards present in the peritoneal dialysis. b) operation of the protection system should be able to prevent air from entering the application part, or the following safety conditions to be achieved. --- stop operation of the pump; --- trigger the alarm sound and light. After a review of random files and functional testing to verify compliance. 51.104 dialysate excess perfusion a) the device shall be equipped with a protection system, in order to prevent excessive liquid to enter the patient's abdominal cavity causing safety hazard. b) operation of the protection system should implement the following safety conditions. --- stopping the flow of dialysis fluid to a patient; --- trigger the alarm sound and light. After a review of random files and functional testing to verify compliance. 51.105 Protection System Fault protection system according to any specific requirements of the standard, let be apparent to those skilled in the start of treatment operations. After a review of random files and functional testing to verify compliance. Chapter 9. abnormal operating and fault states; Environmental Testing "Common Criteria" Benpian chapter shall apply. Tenth Canto structural requirements Except as follows, "common standards" Benpian chapter shall apply. And a wiring structure 59 Except as follows, "universal standard" Chapter applies. GB 9706.39-2008/IEC 60601-2-39.2003 increase. 59.101 dialysate line guide If the dialysate line is not installed properly, the patient may have dangerous security. Shall be provided to ensure that the dialysate line Correct devices. By checks to verify compliance. 59.102 drainage You should at any time can be draining. By function tests to verify compliance. GB 9706.39-2008/IEC 60601-2-39.2003 appendix General Standard Appendices A to L apply. GB 9706.39-2008/IEC 60601-2-39.2003

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