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¡ñ ÌåÍâÕï¶ÏÀà×°±¸ / in vitro diagnostic medical devices
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ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆø×°±¸µÄÇå¾²ÒªÇó Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
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2 |
ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆø×°±¸µÄÇå¾²ÒªÇóµÚ2-101²¿·Ö£ºÌåÍâÕï¶Ï(IVD)Ò½ÓÃ×°±¸µÄרÓÃÒªÇó Safety requirements for electrical equipment for measurement, control and laboratory use –Part 2-101: Particular requirements for in vitro diagnostic (IVD) medicalequipm |
IEC/EN 61010-2-101 |
YY 0648 |
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3 |
ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõçÆø×°±¸µÄÇå¾²ÒªÇó£ºÊµÑéÊÒÓÃÆÊÎöºÍÆäËûÄ¿µÄ×Ô¶¯ºÍ°ë×Ô¶¯×°±¸µÄÌØÊâÒªÇó Safety requirements for electrical equipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081 |
GB4793.9 |
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4 |
ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõĵç×°±¸ µç´Å¼æÈÝÐÔÒªÇó µÚ1²¿·Ö:ͨÓÃÒªÇó Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements |
IEC/EN 61326-1 |
GB/T 18268.1 |
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5 |
ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõç×°±¸.µç´Å¼æÈÝÐÔ(EMC)µÄÒªÇó.ÌØÊâÒªÇó.ʵÑéÊÒÕï¶Ï Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
IEC/EN 61326-2-6 |
GB/T18268.26 |
¡ñ ÉúÎïÏàÈÝÐÔʵÑé / Biological evaluation of medical devices
| ¼ì²âÏîÄ¿ | ²ÎÕÕ±ê×¼ |
| ϸ°û¶¾ÐÔÊÔÑé | GB/T 16886.5/ISO 10993-5/GB/T 14233.2/ISO 7405/YY/T 0127.9/YY 0719.7 |
| ÖÂÃôÊÔÑé | GB/T 16886.10/ISO 10993-10/GB/T 14233.2/GB15979/ YY/T 0879.2 |
| Ƥ·ô´Ì¼¤ÊÔÑé | GB/T 16886.10/ISO 10993-23/GB 15979/YY 0719.7 |
¡ñ Èí¼þ²âÆÀ / Software evaluation
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The software evaluation service includes general software evaluation, APP security test , information security.
¡ñ GB/T 25000.51-2016¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ51²¿·Ö£ºÍ£µ±¿ÉÓÃÈí¼þ²úÆ·£¨RUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò¡·
¡ñ IEC/ISO25051
¡ñ GB/T 25000.10-2016 ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ10²¿·Ö£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£×Ó IEC/ISO25010
¡ñ ÍøÂçÇå¾²ºÍÎó²îÆÀ¹À
¡ñ YY/T1843-2022 Ò½ÓõçÆøϵͳ¼°Ò½ÁÆÆ÷еÈí¼þµÄÍøÂçÇå¾²»ù±¾ÒªÇó
¡ñ IEC/TR80001-2-2 Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
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