ISO 14971改定について

医療機器には何かしらのリスクが存在する。リスクを推定しリスクをコントロールすることは極めて重要である。リスクは試すことが出来ないため、設計前に十分に検討しておくことが必要となる。

ISO 14971「医療機器－リスクマネジメントの医療機器への適用」の改定版が来月にも発行される見込みだ。
すでに2019年5月にFDIS（Final Draft International Standard）が発行されていた。
ISO 14971はメンテナンスサイクルを2回オーバーしてしまった。したがって2007年から12年を経ての改定である。
これまで改定できなかった理由は、100以上もの規格がISO 14971を参照しているため、大幅な改定による影響が懸念されたためである。

改定版では、ISO 14971:2007の附属書のほとんどがISO/TR 24971に移動される予定である。
TRとはTechnical Reportのことで、ISO 14971に適合するための方法（How）を詳しく記載したものである。
TRが発行されることの意義は大きい。
ISO 14971本体には要求事項（What）が記載されている。つまり本体にはWhyやHowは記載されていないのである。もし本体にHowを記載してしまっては、その通り実施していない企業の場合、指摘を受けてしまうことになる。
そこでISO 14971本体にはWhatだけを残し、HowについてはTRに移動させるのである。
ISO 14971を正確かつ適切に理解するためには、ISO/TR 24971を読みこなすことが必要である。

ISO 14971:2019では、新たな技術分野および医療機器の使用環境等の変化に合わせた更新・追加等が含まれている。
例えば、昨今のネットワーク社会においては、インターネットに医療機器を接続することも少なからず発生する。
しかしながらサイバーテロなどの脅威に備えなければならない。セキュリティの強化が求められるのである。
また医療機器は、医療機関や検査室でのみ使用されるものではない。
例えば、駅のコンコースで野次馬に囲まれて取扱説明書も読まずに初めて使用するAEDだってある。
緊急搬送中の救急車の中で振動を受けながら使用しなければならない血圧計や心電図系などもある。
さらに子供が自宅で使用するペンタイプの注射器もある。

特に喫緊の課題は、ユーザビリティであろう。
ユーザビリティと聞くと「使いやすさ」を想像すると思われるが、そうではない。
わざと使いにくくすることもユーザビリティなのである。
例えば、使い捨てのライターのノックは重くしてある。つまりわざと使いにくくしている。これは子供がいたずらをして火事を起こさないためである。
ユーザビリティは、医療機器のインターフェイスに注目したヒューマンエラーを回避・軽減するための要求事項である。

医療機器における事故は、設計者の設計思想（取扱説明書：設計者の意図した利用）とユーザの判断（ユーザの意図した利用）のギャップによって発生すると言われている。
ますます多様化し複雑化する医療機器において、ユーザが直感的に操作できることが重要である。
また、例え操作を間違った場合でもフェールセーフ機構が安全に機能しなければならない。
ユーザビリティに関する規格はIEC 62366-1であるが、間もなくJIS化され、本邦においても要求事項となる予定である。

しかしながら、ISO 14971やIEC 62366は難解である。また企業によっては異なる解釈をしているところもある。
適正な解釈と理解、そして適切な実施が求められる。

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