Standardization Division
Activity Report
1. Introduction
Following the basic policy of "standardization based on international harmonization", Standardization Division is working to accelerate deliberation of the IEC drafts in cooperation with the "IEC/SC Subcommittee", and also organizes the "JIS Draft Creation Subcommittee" to promote the translation of IEC standards into JIS drafts. This report introduces the IEC drafts we deliberated and the JIS drafts we created during FY2007.
Moreover, we joined the "Technical Standard for Shonin(MHLW approval) and Ninsho(3rd party certification) WG", which is the subordinate organization of the Regulation and Safety Division, to address the issues related to the revised Pharmaceutical Affairs Law(PAL) enforced in FY2005.
2. Deliberations on the IEC standards
The 3rd edition of IEC 60601-1 (Medical electrical equipment - General requirements for safety and essential performance) was published in December 2005. In order to harmonize this standard, the related IEC committees are progressively engaged in deliberation and establishment of the particular standards. We sent representatives to the international conferences and arranged the meetings. At the same time, we deliberated 30 IEC standards and submitted the replies (ballot).
3. Creation of JIS draft
We deliberated and created the JIS drafts in FY2007 as follows:
(1) The revision draft of JIS Z 4918 "X-ray film viewer"
Since the previous revision, thirteen years have passed. In the meantime, high brightness X-ray film viewer is used at the clinical site, and the film-printing methods have been changed. So, revision became necessary. At the same time, we specified the applicable items of JIS T 0601-1 (Medical electrical equipment-Part 1: General requirements for safety).
(2) The draft for the establishment of JIS Z 4121 "Determination of the permanent filtration of X-ray tube assemblies "
The present standard "JIS Z 4704 X-ray tube assemblies for medical use" was established with reference to several IEC standards. In order to harmonize it with IEC standards, we are working to divide it into individual standard. The captioned draft is to specify only the permanent filtration. The corresponding international standard is IEC 60522 Ed.2 (1999) "Determination of the permanent filtration of X-ray tube assemblies".
(3) The draft for the establishment of JIS Z 4122 "Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis"
Just as the above item (2), the captioned draft is to become an identical standard with the IEC standard that is referred to by JIS Z 4704. The corresponding standard is IEC 60806 Ed.1 (1984) "Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis".
4. International harmonization of JIS standards that become certification criteria of X-ray equipment
The revised PAL enforced in FY2005 adopted JIS as the criteria for certification and approval. The present JIS Z 47XX series refers to IEC standards. But, many of JIS are peculiar to Japan, and are not identical with the international standards. We worked to replace some of JIS Z 47XX series by JIS standards, so called as IDT(Identity), that were harmonized with IEC standards. As shown in Table 1, we replaced the present JIS by the IDT, and made the draft proposal of revised 16 criterias for certification of X-ray equipment.
We, through the "Technical Standard for Shonin and Ninsho WG", are asking the competent authorities to release these revisions by the end of FY2008.
| Table 1 Replacement of the present JIS by IDT(Identity) |
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Note 1)
JIS Z 4701 corresponds IEC 60601-1 and IEC 60601-1-3, however, it refers only to IEC 60601-1 Ed.2 (parent standard) for the purpose of certification criteria. So, it is suggested to notice only IEC 60601-1-3 as its correspondence in the public bulletin.
Note 2)
IEC 60601-2-32 does not require IDT because of the following reasons.
(1) IEC 60601-2-32 is not substantially different from JIS Z 4703.
(2) The requirements of IEC 60601-2-32 are incorporated into IEC 60601-1 Ed.3.
(3) IEC 60601-2-32 is scheduled to be withdrawn in the future.
Medical Imaging System Division
ISO/TC215 WG4 Goteborg Meeting Report
Introduction
The Working Group (WG) meeting of ISO/TC215 (Health Informatics) was held in Goteborg, Sweden from May 30 to June 1, 2008. I participated in WG4 (Security). This report describes what standards are being deliberated in WG4 and what activity Japan is performing.
The Goteborg Meeting
The meeting lasted from 9:00 till 17:00 every day. Each proposed standard was deliberated for two hours by each task force (TF).
The WG4 participating countries included Canada, UK, Sweden, Germany, Finland, US, Brazil, Turkey, Korea, Australia and Japan. Although it depended on the TF, 20 persons joined each meeting on average. The present chairperson is Mr. Ross Fraser, a representative of Canada.
The main contents deliberated at this meeting are detailed below. In the text, IS is International Standard, TS is Technical Specification, and TR is Technical Report. They indicate the types of ISO standards.
Risk management-related standards
The risk management is intended to ensure security. It is defined as a workflow, which is performed through a PDCA cycle of identifying the assets to be protected, analyzing the threats to the assets, taking countermeasures against the threats, and evaluating the risk. The typical standards are ISO27000 (Health Informatics) series for information-related risk management.
The two following standards are now under deliberation.
- ISO/TS29321 “Application of clinical risk management to the manufacture of health software”
- ISO/TR29322 “Guidance on the management of clinical risk relating to the deployment and use of health software systems”
TS29321 is a standard related with application of risk management to the development venders of health software. TR29322 is the guidelines for risk management for users of health software.
These proposed standards will regulate software, which was exempted from regulation. They will overlap with the existing ISO14971, which regulates medical devices, and impose additional burden to medical device venders in terms of development, sales and maintenance. These proposed standards are at the stage prior to the inquiry (DTS; Draft Technical Specification) balloting. Japan will coordinate with each country, and will oppose these standards.
Note:The PDCA cycle is a policy of "the repeated continuation of Plan, Do, Check and Act".
Matters related to EHR (Electronic Health Record)
Europe goes ahead in this field. It has an electronic health record (EHR) of an individual for a whole lifetime. CEN (Comité Européen de Normalisation) specified EHR as 13606 series. Part 4, which concerns security, is proposed as TS. Other parts of standards are being studied by other TFs.
- CEN 13606 “Electronic health record communication – Part 4: Security”
This defines the access control and the audit trail to ensure interoperability of EHR. Japan is also paying much attention to this standard. The harmonization of this standard with other ISO standards is under examination.
Infrastructure-related standards
These standards are related to the infrastructure to realize security. The following standards are under examination.
- ISO/IS27789 “Audit Trails for electronic health records”
- ISO/TS21547 “Secure archiving of electronic health records”
TS27789 is related with the audit trail and is almost the same as ATNA(Audit Trial Node Authentication Profile) of IHE. It is scheduled to proceed to the ballot at committee draft. TS21547 is related with prolonged storage. It is scheduled to proceed to the inquiry stage (DTS).
The proposal from Japan
ur policy is that Japan should actively propose standards. JIRA and JAHIS*1 proposed jointly the following TRs: Remote service security guide (JESRA C 0012-2004) and Remote service security guidelines (JESRA*2 C 0013-2006). We submitted drafts (CD; Committee Draft) and reviewed the comments from Germany. The draft was approved with voting by a majority within TC(Technical Committee). This is a TR(Technical Report), so the next stage is publication.
The draft of the dynamic on-demand VPN(Virtual Private Network) was explained by HEASNET (Healthcare Information Secure Network Consortium).
*1 JAHIS; Japanese Association of Healthcare Information Systems Industry
*2 JESRA; Japan Engineering Standards of Radiological Apparatus
In conclusion
It was for the fifth time that I participated in ISO/TC215 WG4. Accordingly as I have become used to the proceedings of the agenda, I see the intention of each country that wants to propose and establish standards. For example, UK proposed the risk management of software (ISO/TS29321) and wanted to emulate the ISO 27000 series and to consider their certification system as a business model. In the case of international standards, it is important not only to examine the standard but also to determine our stance by assuming the intention of each country's proposal. This is my feeling. I would like to address ISO activity, gather information, submit comments to working groups, and send information to JIRA members. The members' understanding and cooperation would be much appreciated.
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