1、Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA. 19428-2959, United States. F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers F 2172 2CONTENTS Page INTRODUCTION 3 SECTION ONE - GENERAL Clause 1 Scope and object 4 2 Terminolo
2、gy and definitions 5 3 General requirements 6 6 Identification, marking and documents 6 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 8 SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 44 Overfl
3、ow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility 8 45 Pressure vessels and parts subject to PRESSURE 9 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data 9 51 Protection against
4、hazardous output 10 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions 12 SECTION TEN - CONSTRUCTIONAL REQUIREMENT 56 Components and general assembly 14 Appendix/Annexes L References - Publications mentioned in this standard 15 AA R
5、ationale to particular sub-clauses 16 BB Test method for hemolysis 19 F 2172 3In this Specification Standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type. explanations, advice, introductions, general statements, exceptions and
6、 references: in smaller type. test specifications: in italic type. TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2 AND IN IEC 601-1: SMALL CAPITALS. INTRODUCTION This Standard Specification amends and supplements IEC 601-1 (second edition, 1988): Medical electrical
7、 equipment - Part 1: General requirements for safety. as amended by its amendment 1 (1991) and its amendment 2 (1995), hereinafter referred to as the General Standard (see 1.3). This Standard Specification is necessary because of the special attention which has to be given to FLUID WARMERS, which ar
8、e frequently used for PATIENTS in operating theaters, intensive care units, and other situations. Additional requirements for safety, beyond those stated in the General Standard, are specified. While K (degree Kelvin) is the recognized unit and symbol for absolute temperature and temperature differe
9、nce, nevertheless the C has been used throughout this Specification Standard because all measurements will commonly be made using equipment marked with the Celsius temperature scale. An asterisk (*) by a clause or sub-clause number indicates that some explanatory notes are given in annex AA at the e
10、nd of this Specification Standard. F 2172 4MEDICAL ELECTRICAL EOUIPMENT - Part 2: Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers SECTION ONE - GENERAL The clauses and sub-clauses of this section of the General Standard apply, except as follows: 1 Scope and object This cl
11、ause of the General Standard applies except as follows: 1.1 Scope Addition: This Standard Specification specifies requirements for FLUID WARMERS as defined in 2.2.101. 1.2 Object Addition: The object of this Standard Specification is to establish requirements for FLUID WARMERS which minimize hazards
12、 to PATIENT and OPERATOR and to specify tests by which compliance can be verified. 1.3 Particular Standards Addition: This Standard Specification refers to IEC 601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, as amended by its amendments 1(1991) and 2 (1995). For
13、 brevity Part 1 is referred to in this Standard Specification either as the General Standard or as the General requirement(s). The numbering of sections, clauses and sub-clauses of this Standard Specification corresponds to that of the General Standard. The changes to the text of the General Standar
14、d are specified by the use of the following words: “Replacement” means that the clause or sub-clause of the General Standard is replaced completely by the text of this Standard Specification. “Addition” means that the text of this Standard Specification is additional to the requirements of the Gener
15、al Standard. “Amendment” means that the clause or sub-clause of the General Standard is amended as indicated by the text of this Standard Specification. F 2172 5Sub-clauses or figures which are additional to those of the General Standard are numbered starting from 101. Additional annexes are lettere
16、d AA, BB, etc., and additional items aa), bb), etc. The term “this Standard” is used to make a reference to the General Standard and this Standard Specification taken together. Where there is no corresponding section, clause or sub-clause in this Standard Specification, the section, clause or sub-cl
17、ause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Standard Specification. 1.101 Equipment excluded This
18、Standard Specification does not apply to: - Non-inline fluid warmers, e.g. warming cabinets, fresh frozen plasma/frozen red cell thawing devices, electric bowl heaters - Extracorporeal / open-heart bypass warming circuits - Fluid warmers integral to dialysis units 2 Terminology and definitions This
19、clause of the General Standard applies except as follows: 2.1 EQUIPMENT Parts, Auxiliaries and ACCESSORIES Additional definition: 2.1.101 FLUID PATH The channel through which the product intended for PATIENT infusion or irrigation flows in-line (through a closed pathway) from its source (e.g., blood
20、 bag, intravenous solution bag, or irrigation fluid bag) to the PATIENT. The fluid path is an APPLIED PART. 2.2 E QUIPMENT types (classification) Additional definitions: 2.2.101 FLUID WARMER EQUIPMENT intended to warm fluid as it passes in-line (through a closed pathway) from its source (e.g., blood
21、 bag, intravenous solution bag, or irrigation fluid bag) to the PATIENT. This includes: - In-line blood warmers - In-line intravenous fluid warmers - In-line irrigation fluid warmers 2.10 Operation of EQUIPMENT Additional definitions: *2.10.101 SET POINT TEMPERATURE The temperature, which may be OPE
22、RATOR adjustable, used by the FLUID WARMER as the desired temperature F 2172 6of the blood, Intravenous solution or irrigation fluid. 2.10.102 ACTIVE CONTROLLED TEMPERATURE The temperature displayed by the FLUID WARMER and derived from a sensor in the FLUID WARMER. 2.10.103 OUTPUT FLUID TEMPERATURE
23、The temperature of the fluid at the exit of the FLUID PATH. 2.12 Miscellaneous Additional definition: 2.12.101 HEMOLYSIS Alteration, dissolution, or destruction of red blood cells in such a manner that hemoglobin is released into the medium in which the cells are suspended. 2.12.102 RISK ASSESSMENT
24、Overall process of risk analysis and risk evaluation (ISO/IEC Guide 51: 1999, definition 3.12) 2.12.103 HEAT TRANSFER FLUID A liquid or gas used to indirectly transfer heat to the blood, intravenous solution or irrigation fluid. 3 General requirements This clause of the General Standard applies exce
25、pt as follows: 3.6 The following SINGLE FAULT CONDITIONS are the subject of specific requirements and tests in this Standard. Additional item: aa) contact between a PATIENT and the HEAT TRANSFER FLUID caused by a leak from the device (see Section Three). 6 Identification, marking and documents This
26、clause of the General Standard applies except as follows: 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts Additional items: aa) FLUID WARMERS EQUIPMENT or EQUIPMENT parts shall be marked as follows: 1) Where appropriate: to warn against possible SAFETY HAZARDS from penetration by sharp ob
27、jects. 2) To specify, in the case of EQUIPMENT parts supplied or controlled by an external sensing device, that F 2172 7the EQUIPMENT shall only be used with the external sensing device specified by the manufacturer of the EQUIPMENT. 3) FLUID WARMERS not intended for use with blood products (Irrigat
28、ion FLUID WARMER) shall be clearly labeled. 6.3 Marking of controls and instruments Addition: aa) FLUID WARMERS shall display SET POINT TEMPERATURE upon OPERATOR demand. FLUID WARMERS with a fixed SET POINT TEMPERATURE shall be labeled with that value. (See also 50.1) 6.8 ACCOMPANYING DOCUMENTS 6.8.
29、1 General Addition: If appropriate the following shall be included in full in the ACCOMPANYING DOCUMENTS (see also 6.1 d) of the General Standard): - all markings specified in 6.1 aa) Additional item: 6.8.2 aa) FLUID WARMERS The instructions for use shall contain the following: - A recommendation th
30、at the EQUIPMENT or EQUIPMENT parts be checked for mechanical damage prior to each use. - If applicable, statements, details and warnings on the use of the FLUID WARMER in combination with other heat sources (i.e. preheated fluid bags). - Particulars of any necessary calibration procedure to be perf
31、ormed by the OPERATOR or USER. - Information as to how to test an alarm system if the alarm system is not tested automatically when the EQUIPMENT is switched on. - Information as to how the OPERATOR can confirm that the independent THERMAL CUT-OUT is functioning correctly. - If the FLUID WARMER cont
32、ains a mains failure alarm, a statement to that effect. F 2172 8SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS The clauses and sub-clauses of this section of the General Standard apply, except as follows: 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS This clause of the Gener
33、al Standard applies except as follows: 19.2 SINGLE FAULT CONDITIONS Addition to 19.2 a): - Perforation of APPLIED PART, heated by circulation of a liquid HEAT TRANSFER FLUID. The liquid is replaced by isotonic saline (0.9g sodium chloride per liter of water). The PATIENT LEAKAGE CURRENT is measured
34、in the saline. - perforation of the APPLIED PART containing an electrical component (e.g., heating element, wire, temperature sensor) SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS The causes and sub-clauses of this section of the General Standard apply. SECTION FIVE PROTECTION AGAINST HAZARDS F
35、ROM UNWANTED OR EXCESSIVE RADIATION The causes and sub-clauses of this section of the General Standard apply. SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES The causes and sub-clauses of this section of the General Standard apply. SECTION SEVEN PROTECTION AGAI
36、NST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS The Clauses and sub-clauses of this section of the General Standard apply, except as follows: 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility This clause of the General Standard
37、applies, except as follows: 44.3 Spillage Replace test method with the following: The EQUIPMENT is positioned as in NORMAL USE. 200ml of isotonic saline (0.9g sodium chloride per liter of water) is poured steadily on an arbitrary point on the top surface of the EQUIPMENT, for approximately 15 s, fro
38、m a height not exceeding 5 cm. After the test, the EQUIPMENT shall comply with all the requirements of this Standard for NORMAL CONDITION. F 2172 944.4 Leakage Addition: Means for drainage of fluid leaking from the EQUIPMENT shall be provided. Compliance is checked by inspection. 45 Pressure Vessels
39、 and Parts Subject to PRESSURE This clause of the General Standard applies, except as follows: Addition: *45.101 The FLUID PATH shall withstand 375mm Hg pressure or 1.25 times the manufacturer maximum recommended pressure, whichever is greater. Compliance is checked by the following test method. The
40、 FLUID PATH is primed with water according to manufacturers instructions and the SET POINT TEMPERATURE is set to its maximum value. With the output clamped, pressurize the FLUID PATH to 377mm Hg pressure or 1.25 times the recommended pressure, whichever is greater and maintain for two minutes. The F
41、LUID PATH shall not leak. SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT The clauses and sub-clauses of this section of the General Standard apply except as follows: 50 Accuracy of operating data This clause of the General Standard applies except as follows: Addit
42、ion: *50.1.101 Temperature Indication There shall be a visual temperature indicator capable of displaying the ACTIVE CONTROLLED TEMPERATURE. Compliance is checked by inspection. 50.2 Accuracy of controls and instruments This clause of the General Standard applies except as follows: Additional sub-cl
43、auses: 50.2.101 Resolution Minimum resolution of the visual temperature indicator shall be 2 degrees C. Compliance is checked by inspection. F 2172 1050.2.101 Accuracy The visual temperature indicator shall have an accuracy of 2 degrees C or better. Compliance is checked by measurement. 51 Protectio
44、n against hazardous output This clause of the General Standard applies, except as follows: Additional sub-clauses: *51.101 Thermal HEMOLYSIS protection The FLUID WARMER shall not cause thermal HEMOLYSIS at levels that constitute a SAFETY HAZARD. Compliance for protection from HEMOLYSIS caused by the
45、rmal exposure is checked by the following test method. Figure 101 Thermal Hemolysis Prevention Limits4545.54646.54747.54848.54949.55050.55151.50 5 10 15 20 25 30 35 40 45 50 55 60Time (Minutes)Temperature (C)Water at a temperature of 10 degrees C ( 2) is passed through the system and the fluid tempe
46、rature at the warmest location within the FLUID PATH is measured. A minimum of three flow rates are required to be tested: maximum flow rate ( per manufacturers specification) of the device, mid-range flow rate, and minimum flow rate no greater than 100ml/hour. Test shall be run until steady state i
47、s achieved or up to a maximum time of fifteen minutes. The time/temperature combinations of the water for each half-degree increment beginning with 46 degrees C shall remain below the values shown in Figure 101 (Thermal Hemolysis Prevention Limits). F 2172 11From each of the three flow rates, clamp
48、the output (stop flow). Monitor the temperature until the value stays below 46 degrees. The time/temperature combinations of the water for each half-degree increment beginning with 46 degrees shall remain below the values shown in Figure 101 (Thermal Hemolysis Prevention Limits). For any time-temper
49、atures combinations above the values shown in Figure 101 an accepted alternate test method to show compliance is to measure hemolysis under the same test conditions. *51.102 Mechanical HEMOLYSIS Protection Whether a FLUID WARMER will cause HEMOLYSIS due to the mechanical influences it imposes on the blood should be initially assessed by inspection. Influences above and beyond those posed by the tubing, fittings, filters and needles commonly used in blood administration sets should be tested by the method in Annex BB. *51.103 Protection against PATIENT
