Session 2.2 Product technical requirement
1. Learning objective
In this session you should know the content of Product technical requirement and context with type testing.
2. Video
3. Product technical requirement (PTR)
a. What is PTR?
Product technical requirement (PTR) is document submitted to testing institutes by manufacturer. As described in Chinese certificate it is a characteristic part of product indicating all key specifications and testing methods derived from Chinese standards whereby the testing institutes check own testing capability and accept the application of type testing by manufacturer.
Don’t be surprised that PTR should be the first created document after the project start of product registration in China. The reason is that the following type testing lasts long and the correlated performance specifications can then be represented in all submission dossiers. The final report will be issued by institute not always in time after completion of testing.
This is one of most important documents at submission dossiers. As a basis for type testing PTR is a kind of design input. The testing institutes will execute type testing in proposed testing method in accordance with national and industrial standards. For e.g. electronic active MD, the heavy weights of typical type testing are safety - and Electromagnetic Compatibility on-site test in China. The final issued testing report acts as a design output.
b. Content of PTR
The PTR is made of four chapters including appendix. We just list some typical items at PTR as overview. In the fact is the PTR is individual different owing to product group and design of each manufacturer.
1) Product name, variants and models:
• Name, variant and model of medical device
• Naming rule of product version (e.g. Easy Ventilator Innovation Version 1.2.0)
• Complete product release version
• Explanation of difference of products variants and models
2) Performance specification
It includes the main functional specifications of medical device as safety, software, quality control, modes.
* the name of this chapter is confusing. Actually many electric parameter is not listed in PTR and will be tested in safety and EMC test. So exact here are critical specification impacting safety and effectiveness of product.
The performance parameters in product technical requirements refer to the functional and safety specification of finished products that can be judged objectively.
e.g.
- Product size and weight
- Product composition and configuration
- Environment and electrical power requirements
- Transport and storage conditions
- Software environment
- Data interface
- Clinical function
- User access control
Not suggested in chapter 2 Performance specifications: validity studies, Sterilization validation studies, fatigue studies, in vitro degradation studies, human factor validation studies, reliability validation studies, magnetic resonance compatibility studies, biocompatibility studies, environmental requirements for medical electrical appliances.
3) Testing methods
Here the applied chapters of Chinese standards and summarised methods are described. If no Chinese standards as method were to reference, manufacturer should suggest method from own internal test.
4) Definition the key definitions are cleared.
Typical Annex
- Insulation diagram in accordance with GB 9706.1-2020 (corresponding to IEC 60601-1:2005)
- Table of Insulation parameters (Insulation path, Insulation type, Electrical clearance, Creepage distance)
- Table of environmental adaptability requirements
- System architecture diagram
- Physical topology diagram
- User interface diagram
- Material list
For medical device, if possible, some descriptive characteristics can be indicated in appendix, such as product sterilization or non-sterile status, product validity period, main raw materials, production work flow, product main safety features, technical specifications, key component information, MRI compatibility etc.
c. Interrelation of PTR with others
Actually the role of PTR is vital through the life cycle of medical device. It is a part of design input at quality control regarding the safety and functional specification. The specification should be already verified at internal test. In figure below is shown interaction of PTR with other topics.
& Guidance/standards
The source of testing method at PTR is often from product specific guidance and Chinese standards. With these referenced requirements it makes the testing method reliable and reproducible.
& Type testing
The testing institute can only test the sample upon drafted PTR and issues the report.
& Product registration
As one annex of Chinese certificate the original PTR is needed for each registration.
& Clinical trial
PTR has to be submitted by the application of clinical trial. It means automatically that the clinical trial can only take place after successful type testing.
& IFU
The final specification after type testing should be consistent with all marketing material especially instruction for use.
& Tender
At sales and distribution activity like tender at hospital is PTR plus chinese certificate a must to have PASSPORT to demonstrate the approved medical device and the functional specifications.
& Post market inspection
At inspection the product specifications in PTR are preferentially proved as one of the most popular findings by authority.
