IMDRF/RPS WG/N50FINAL:2018 Round 2, RPS Beta Testing Report - PDF (694kb)
标准简介
Round 2, RPS Beta Testing Report - PDF (694kb)[附网盘链接]由Regulated Product Submission Working Group于27 July 2018发布，适用于世界范围。标准截图
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标准文档说明
标准文档类型为Round 2, RPS Beta Testing Report - PDF (694kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
1.0 Introduction
Regulated Product Submission (RPS) is a messaging standard produced by HL7 that is designed
to enable electronic submission of regulated products – including drugs, devices, food and
veterinary medicines. The IMDRF RPS Working Group evaluated the Regulated Product
Submission (RPS) standard to assess whether the standard can meet medical device needs as a
harmonized electronic submission format.
As part of the IMDRF evaluation the working group performed “beta” testing of medical device
submission scenarios to verify the RPS standard can effectively convey required submission
information. Testing was conducted in two phases (rounds). Results from the first round of
testing is documented in IMDRF/RPS WG/N21FINAL:2014.
2.0 Scope
This document summarizes the testing approach and results from the second and final round of
IMDRF beta testing.
3.0 References
IMDRF/RPS WG/N21FINAL2014 RPS Beta Testing Document
HL7 RPS Standard, DSTU (the version of the standard that was used during testing)
4.0 Definitions
RPS: Regulated Product Submission. An HL7 standard currently being tested by the IMDRF
RPS Working Group.
HL7: Health Level 7.
Test Case: One message within a Test Case Scenario.
Test Case Scenario: A collection of 3 – 5 test cases that are tested together in a particular order.
The test case scenario follows a business process that is being tested.
Message: The XML file accompanying the documents contained in the submission unit. The
XML file structure is defined by the RPS standard and provides information about how the files
included should be reviewed.
Submission Unit: A package of documents to support a regulatory activity that is sent and
received together. In paper terms, this is the fed-ex box containing a packet of information sent
from industry to the regulator. In RPS terms, this includes the “message” / submissionUnit.xml
file as well as the accompanying submission files.
27 July 2018 Page 4 of 88
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