×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪȫÇò¿Í»§Ìṩһվʽ¼ìÑé¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°¼¼Êõ·þÎñ¡£
·þÎñÄÜÁ¦ÒÑÈ«ÃæÁýÕÖµ½·ÄÖ¯·þ×°¼°Ð¬°ü¡¢Ó¤Í¯Íæ¾ß¼°¼Ò¾ÓÉú»î¡¢µç×ÓµçÆ÷¡¢Ò½Ñ§½¡¿µ¡¢Ê³Æ·¼°Å©²úÎï……µÈÐÐÒµµÄ¹©Ó¦Á´ÉÏÏÂÓΡ£
È«Ãæ±£ÕÏÆ·ÖÊÓëÄþ¾²£¬Íƶ¯ºÏ¹æÓ봴У¬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü½¡¿µ¡¢¸üÄþ¾²¡¢¸üÂÌÉ«µÄ¿ÉÁ¬ÐøÉú³¤¡£
Ê×Ò³ > ÎÒÃǵķþÎñ > Ò½Ò©¼°Ò½Ñ§·þÎñ > Ò½ÁÆÆ÷е¼ì²â > ·þÎñÏêÇé
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩҽÓûúÆ÷ÈË×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢ÉúÎïÏàÈÝÐÔ²âÊÔ¡¢Èí¼þ&ÍøÂçÄþ¾²²âÊÔ¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾Ò½ÓûúÆ÷ÈË¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢ÉúÎïÏàÈÝÐÔ²âÊÔ¡¢Èí¼þ&ÍøÂçÄþ¾²²âÊÔ¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
ÏîÄ¿ | ²âÊÔ³ß¶È |
EMC | YY 9706.102 | IEC 60601-1-2£¨EMC£© |
°²¹æ | GB 9706.1 | IEC 60601-1 |
YY/T 9706.106 | IEC 60601-1-6£¨¿ÉÓÃÐÔ£© | |
YY 9706.108 | IEC 60601-1-8£¨±¨¾¯£© | |
GB/T 14710£¨Ò½ÓõçÆ÷»·¾³ÒªÇó£© | |
YY 1057-2016£¨Ò½ÓýÅ̤¿ª¹Ø£© | |
YY 9706.277 | IEC 80601-2-77£¨ÊÖÊõ»úÆ÷ÈË£© | |
YY 9706.278 | IEC 80601-2-78£¨¿µ¸´»úÆ÷ÈË£© | |
GB 9706.202 | IEC 60601-2-2£¨¸ßƵÊÖÊõÉ豸£© | |
GB 9706.218 | IEC 60601-2-18£¨ÄÚ¿ú¾µÉ豸£© | |
YY/T 1712 ( ½ÓÄÉ»úÆ÷È˼¼ÊõµÄ¸¨ÖúÊÖÊõÉ豸ºÍ¸¨ÖúÊÖÊõϵͳ ) | |
YY 9706.241 / IEC 60601-2-41£¨¸½´øÄÚ¿ú¾µÕÕÃ÷ϵͳ£© | |
GB 9706.222 | IEC 60601-2-22£¨¼¤¹âÉ豸£© | |
GB 9706.237 | IEC 60601-2-37£¨³¬ÉùÕï¶ÏºÍ¼à»¤É豸£© | |
YY 9706.246 | IEC 60601-2-46£¨ÊÖÊǫ̃£© | |
YY/T 1750-2020£¨³¬ÉùÈí×éÖ¯ÇиîֹѪÊÖÊõÉ豸£© | |
YY/T 1601-2018£¨³¬Éù¹Ç×éÖ¯ÊÖÊõÉ豸£© | |
YY/T 1587 £¨µç×ÓÄÚ¿ú¾µ£© | |
YY/T 0069 (Ó²ÐÔÄÚ¿ú¾µ) | |
YY/T 1028 £¨ÏËάÄÚ¿ú¾µ£© | |
YY/T 1298 (½ºÄÒʽÄÚ¿ú¾µ) | |
YY/T 0619 £¨Ó²ÐÔµçÄýÇиîÄÚ¿ú¾µ£© | |
YY/T 0070 £¨Ê³¹Ü¿ú¾µ£© | |
YY/T 0071 £¨Ö±³¦¡¢ÒÒ×´½á³¦¿ú¾µ£© | |
²úÎïÐÔÄÜ | GB 7247.1 | IEC 60825-1(¼¤¹â·øÉä) |
GB/T 20145 / IEC 62471 (¹âÉúÎïÄþ¾²) | |
YY 0068.1 (Ó²ÐÔÄÚ¿ú¾µ ¹âѧÐÔÄÜ) | |
YY/T 0068.2 (Ó²ÐÔÄÚ¿ú¾µ »úеÐÔÄÜ) | |
YY/T 0068.3 (Ó²ÐÔÄÚ¿ú¾µ ±êÇ©¼°Ë渽ÖÊÁÏ) | |
YY 0068.4 (Ó²ÐÔÄÚ¿ú¾µ »ùÌìÐÔÄÜ) | |
YY 0763 £¨ÕÕÃ÷ÓùâÀ£© | |
YY 1081 £¨Àä¹âÔ´£© | |
YY/T 1603 £¨ÉãÏñϵͳ£© | |
ISO 8600-1£»-2£»-3£»-4£»-5£»-6£»-7 (Ò½ÓÃÄÚ¿ú¾µÐÔÄÜ) |
¿É¿¿ÐÔ²âÊÔºÍʧЧ·ÖÎö Reliability Testing and Failure Mode Analysis
¿É¿¿ÐÔ²âÊÔ£ºIEC 60068,IEC 60529;IEC 60598,EIA-364,MIL-STD-202,ISO 4892,ISO 1431,ASTM G 154,ASTM G155,ASTM D4728,etc.
ʧЧ·ÖÎöÓëÔ¤·À£ºIPC/ECAJ-STD,IPCTM 650-2,ISO 16232-10,etc.
°ü×°ÔËÊäÊÔÑé Packaging Shipping Testing
¹úÄڳ߶ȣºGB/T 4857ϵÁÐ
¹ú¼Ê³ß¶È£ºISTAϵÁÐ / ASTM D 4169
ÉúÎïÏàÈÝÐÔÊÔÑé Biocompatibility Testing
ÆÀ¼ÛÓëÊÔÑ飺GB/T 16886.1/ ISO 10993-1
ϸ°û¶¾ÐÔÊÔÑ飺GB/T 16886.5 / ISO 10993-5
ÖÂÃôÊÔÑ飺GB/T 16886.10 / ISO 10993-10
´Ì¼¤ÊÔÑ飺GB/T 16886.10 / ISO 10993-23
¼±ÐÔÈ«Éí¶¾ÐÔÊÔÑ飺GB/T 16886.11 / ISO 10993-11
¶¾ÀíѧÆÀ¹À£ºGB/T 16886.17 / ISO 10993-17
ÖÊÁÏ»¯Ñ§±íÕ÷£ºGB/T 16886.18 / ISO 10993-18
΢ÉúÎï¼ì²â Microbiological Testing
ÑáÑõ¾ú×ÜÊý£ºGB/T 19973.1 / ISO 11737-1
·ÇÑ¡ÔñÐÔÐèÑõ¾ú×ÜÊý£ºISO 11737-1
΢ÉúÎGB/T 19973.1 / ÖйúÒ©µä
ÒÖ¾úЧÁ¦£ºÖйúÒ©µä
ÎÞ¾úÊÔÑ飺ÖйúÒ©µä / GB/T 19973.2 / ISO 11737-2
½Íĸ¾ú×ÜÊý£ºGB/T 19973.1 / ISO 11737-1
΢ÉúÎïÏ޶ȣºISO 11737
±¸×¢£ºÈôÅäÌ׵ĸ½¼þΪÎÞ¾úʹÓ㬽¨Ò鿼ÂÇÈçÉϲâÊÔÏîÄ¿¡£
»õ¼ÜÆÚÊÙÃüÑéÖ¤ Validation of Product Life
¼ÓËÙÀÏ»¯ÊÔÑ飺YY/T 0681.1 / ASTM F1980-16
·â¿Ú°þÀëÊÔÑ飨ÃÜ·âÇ¿¶È£©£ºYY/T 0681.2 / ASTM F88/F88M
ÕÇÆÆʵÑéºÍÈä±äÊÔÑ飺YY/T 0681.3;ASTM F1140/F1140M
ȾÁÏÉø͸ÊÔÑ飨ÃÜ·âй¶£©£ºYY/T 0681.4 / ASTM F1929-15
Õæ¿Õй¶ÊÔÑ飺YY/T 0681.5
ÃÜ·âÕÇÆÆÊÔÑ飺YY/T 0681.9
Ä¿ÊÓÊÔÑ飺YY/T 0681.11 / ASTM F1886/F1886M
΢ÉúÎïÆÁÕϼì²â£ºYY/T 0681.14 / ISO 11607-1 / GB/T 19633.1
ÈôÅäÌ׵ĸ½¼þΪÎÞ¾úʹÓ㬽¨Ò鿼ÂÇÈçÉϲâÊÔÏîÄ¿¡£
Ãð¾úÈ·ÈÏ Sterilization Validation Services
·øÕÕÃð¾ú£ºGB 18280ϵÁÐ / ISO 11137ϵÁÐ
»·ÑõÒÒÍéÃð¾ú£ºGB 18279ϵÁÐ / ISO11135ϵÁÐ
»·ÑõÒÒÍéÃð¾ú²ÐÁôÁ¿£¨EO/ECH£©£ºGB/T 16886.7 / ISO 10993-7 / GB/T 14233.1
ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤£ºWS 310.1 / WS 310.2 / WS 310.3 / AAMI TIR12 / AAMI TIR30 / FDA Guidance,etc.
±¸×¢£ºÈôÅäÌ׵ĸ½¼þΪÎÞ¾ú¼°Öظ´ÐÔʹÓ㬽¨Ò鿼ÂÇÈçÉϲâÊÔÏîÄ¿¡£
Èí¼þ²âÆÀ¼°ÍøÂçÄþ¾²²âÊÔ Software Evaluation & Network Security testing
GB/T 25000.51 ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£© µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò¡·
GB/T 25000.10 ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ10²¿ÃÅ£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£ÐÍ¡·
YY/T 1843-2022 ¡¶Ò½ÓõçÆøϵͳ¼°Ò½ÁÆÆ÷еÈí¼þµÄÍøÂçÄþ¾²»ù±¾ÒªÇó¡·
IEC/TR80001-2-2 Application of risk management for IT-networks incorporating medical devices
ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏß¿Í·þ¡£
1¡¢NG28¾ßÓÐרҵ×ÊÖÊ¡¢¾Ñ鸻ºñµÄ¼¼Êõר¼ÒÍŶӣ¬ÎªÄúÌṩרҵ×ÉѯºÍ·þÎñ¡£
2¡¢NG28ÓµÓÐÏȽøµÄʵÑéÊÒÉ豸£¬È·±£²âÊÔÊý¾ÝµÄ׼ȷºÍ¿É¿¿¡£
3¡¢NG28×÷ΪȫÇò¿Í»§ÐÅÀµµÄµÚÈý·½²âÊÔÈÏÖ¤»ú¹¹£¬ÎÒÃÇÊÇÄúÆ·Öʵı³Êé¡£
4¡¢ÎÒÃÇƾ½è±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌṩȫÃæÍêÉƵÄһվʽ²âÊÔÈÏÖ¤½â¾ö·½°¸¡£
NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿
ʵ¼ÊÖÜÆÚƾ¾ÝίÍеIJúÎï³ß¶ÈÀ´È·¶¨£¬ÇëÓëNG28¿Í·þÁªÏµÈ·ÈÏ¡£
NG28Ò½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿
Õë¶Ô²úÎïµÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬽øÐг߶ȼì²â¡£
NG28¶ÔÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿
ÍËÑù¡£