目前FDA接受的UDI编码三家发放机构包括GS1国际物品编码协会,HIBCC保健业商务通信委员会和ICCBBA国际血库自动化委员会.其中GS1的使用范围最广,和接受最高,而HIBCC作为专门的医疗行业的编码机构,在医疗行业的使用也较为普遍,医疗产品出口美国,也常被要求使用HIBC编码。
HIBC比UPN、EAN/UPC代码更早。The Health Industry Business Communications Council(HIBCC)成立于1983年,主要是开发使用条码的数据交换标准,是美国标准协会的会员。管理和发放LIC's(the Labeler Identification Codes厂商识别码)。
以以下HIBC编码作为例子,解释HIBC编码的形式和构成
A
* The human readable interpretation of the bar code data should begin and end with the asterisk characters‘*’.The asterisk character must not be encoded in the bar code data.条码以星号*开始和结束。开始和结束码不计入编码中。
B ID mark for Stan­dard标准标识
The plus (+) Sign is the HIBC Supplier Labeling Flag Character(+)符号是HIBC供应商标记标志字符
C Labeler/Location Identification Code (LIC) 贴标者的识别码
Assigned by HIBCC and Identifies the labeler. Begins with a letter, followed by 3 numeric characters.由HIBCC分配的贴标者的识别码
。以一个字母开头,后面跟着3个数字。
D Product /Catalog Number产品/种类编号
The full product or catalog number for the item.
1-13 alphanumeric characters
• A through Z; ASCII(65)–ASCII(90)
•0 through 9; ASCII(48) – ASCII(57)
项目的完整产品或目录号
1-13字母数字字符
由A到ZASCII(65) – ASCII(90),
由0到9ASCII(48) – ASCII(57);
E
Unit of Measure度量单位
Identifies the packaging configuration level of the item; i.e. Unit Package, Case, Master-Case, Pallet, etc. 1 numeric character.
•0 through 9; ASCII(48) – ASCII(57)
用来识别商品包装层次结构,如单体包装,外壳,外包装,托盘等;
1位数字,0到9ASCII(48) – ASCII(57)
F Separator分隔符
The forward slash (/) is used as a separator between the primary and secondary data elements.
前斜杠(/)用作主数据元素(和辅助数据元素之间的分隔符。
G Expiration Date Format
到期日期格式
As part of the HIBC format, manufacturers have the option of encoding a product expiration date (i.e. sterility expiration) by reflecting a five-digit Julian date code (YYJJJ). The expiration date should be encoded into the bar code since the month/year format is reflected with the human readable/hourglass symbol on the product label, the last day of the month should be the day encoded in the Julian date format. Only exceptions to this will be product that has a specific day of the month the product has to expire.
作为HIBC格式的一部分,制造商可以通过五位朱利安日期代码(YYJJJ)来编码到期日期(如无菌过期)。YY是年的最后两位数字,JJJ是一年中的某一日的朱利安日期代码
If no expiration date is encoded, a “$” symbol appears as the system default char­acter, indicating no expiration date for the product is reflected.
如果没有过期日期被编码,则出现“$”符号作为系统默认字符,表示产品没有到期日期。
H Lot Number批号
The product’s lot number or batch number.
产品批号或批号
Field Length: 0-13 alphanumeric characters
字段长度:0—13字母数字字符
• A through Z; ASCII(65)–ASCII(90)
A到Z:ASCII(65) – ASCII(90)
• 0 through 9; ASCII(48)–ASCII(57)
0到9;ASCII(48) – ASCII(57)
I Date of Manufacture Code
生产日期代码
A unique three-character date of manufacture (month/year) code appears after the lot number. A single letter signifies the month, (A-L, where A=Jan, B=Feb, etc.) and two digits signifies the last two digits of the year.一个独特的三个字符的制造日期(月/年)代码出现在批号之后。一个字母表示月份,(A-L,A=一月份,B=二月份等),后两个数字表示年份的最后两个数字。
J Modulus43 Check Character
模块43
校验码
Calculated according to the standard modulus 43 check character formula.根据标准模块43校验字符公式计算
Check character values may be
校验数值如下:
• A through Z; ASCII(65)–ASCII(90)
A到Z:ASCII(65) – ASCII(90)
• 0 through 9; ASCII(48)–ASCII(57)
0到9ASCII(48) – ASCII(57)
•“-“(hyphen or dash–ASCII(45)
•“.”(period or dot)–ASCII(46)
•““(space)–ASCII(32)
•“$”(dollar)–ASCII(36)
•“/”(forward slash)–ASCII(47)
•“+”(plus)–ASCII(43)
•“%”(percent)–ASCII(37)
K Link Character
连接字符
This character is used to link the primary bar code to the secondary bar code. The check character of the primary bar code becomes the link character of the secondary bar code, thus linking the two codes together. (Note: The primary bar code does not contain a link character.)
此字符用于将主条形码连接到辅助条形码。主条码的校验字符成为二级条形码的链接字符,从而将两个代码链接在一起。(注意:主条码不包含连接字符)。