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NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âÌṩÌåÍâÕï¶ÏÀàÉ豸×ۺϲâÊÔ·þÎñ £¬°üÂÞÌåÎÂ¼Æ £¬ÑªÑõÒÇ £¬ÑªÑ¹¼Æ £¬Ì¥ÐÄÒÇ £¬Ðĵçͼ»ú £¬²Ê³¬ £¬X¹â»úµÈÌåÍâÕï¶ÏÉ豸ÌرðÊÇ´©×ÅʽÉ豸°²¹æ¡¢¿É¿¿ÐÔ¡¢Ï¸°û¶¾ÐÔÊÔÑé¡¢ÖÂÃôÊÔÑéµÈÌåÍâÕï¶ÏÉ豸³ö³§×ۺϲâÊÔ·þÎñ¡£
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¡ñ ÌåÍâÕï¶ÏÀàÉ豸 / in vitro diagnostic medical devices
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¹ú¼Ê³ß¶È |
¹úÄÚ³ß¶È |
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1 |
ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇó Electrical Equipment For Measurement, Control ,and Laboratory Use |
IEC/EN 61010-1 |
GB4793.1 |
|
2 |
ÕÉÁ¿¡¢¿ØÖƺÍÊÔÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇóµÚ2-101²¿ÃÅ£ºÌåÍâÕï¶Ï(IVD)Ò½ÓÃÉ豸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¿¡¢¿ØÖƺÍʵÑéÊÒÓõçÆøÉ豸µÄÄþ¾²ÒªÇó£ºÊµÑéÊÒÓ÷ÖÎöºÍÆäËûÄ¿µÄ×Ô¶¯ºÍ°ë×Ô¶¯É豸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 |
|
4 |
ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõĵçÉ豸 µç´Å¼æÈÝÐÔÒªÇó µÚ1²¿ÃÅ:ͨ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¿¡¢¿ØÖƺÍʵÑéÊÒÓõçÉ豸.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¿ | ²ÎÕÕ³ß¶È |
| 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¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò¡·
¡ñ IEC/ISO25051
¡ñ GB/T 25000.10-2016 ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ10²¿ÃÅ£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£ÐÍ IEC/ISO25010
¡ñ ÍøÂçÄþ¾²ºÍ©¶´ÆÀ¹À
¡ñ YY/T1843-2022 Ò½ÓõçÆøϵͳ¼°Ò½ÁÆÆ÷еÈí¼þµÄÍøÂçÄþ¾²»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
Ò½ÁÆÆ÷е²úÎ°üÂÞ£ºÌåÎÂ¼Æ £¬ÑªÑõÒÇ £¬ÑªÑ¹¼Æ £¬Ì¥ÐÄÒÇ £¬Ðĵçͼ»ú £¬²Ê³¬ £¬X¹â»úµÈ£©¡£
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