Health & Bio

IEC 62304:2006 Medical Device Software Lifecycle → KS C IEC 62304 의료기기 소프트웨어 생명주기 → 국가기술표준원 / 식품의약품안전처

국가기술표준원 (KATS) / 식품의약품안전처 (MFDS)

CSuggestive similarity

Evidence tier

Echo patterns are similarity-based hypotheses, not proof of causation. Open the sources and evaluate the linkage yourself.

Evidence Scorecard

Three lenses — wording, timing, documented link. Not a single proof score.

Suggestive similarity

Semantic

Strong semantic alignment

Temporal

Global precedent precedes Korea

Linkage

No recorded linkage

Multilingual semantic similarity

cosine similarity (method detail)0.844

Computed with intfloat/multilingual-e5-small multilingual embeddings. Display score is a calibrated mapping of the raw cross-lingual cosine (0.844); higher means closer meaning. Reflects semantic similarity, not proof of causation.

Aligned sentences

IEC 62304 provides lifecycle processes for safe design and maintenance of medical device software.

aligned

KS C IEC 62304는 IEC 62304를 국내 표준으로 채택하여 의료기기 소프트웨어 생명주기 기준으로 활용한다.

Could also be…show

•Parallel domestic policy development is possible.
•Industry or market pressure may have driven similar language.
•A common external shock (e.g., financial crisis, pandemic) could explain parallel adoption.

Timeline of the echo

9 year lag

From date field: 2015 · 2006-2015

Interrogate the Evidence

Answers are rendered directly from this record’s own curated fields — nothing is generated.

Csuggestive similarity · 65%

SemanticStrong semantic alignment
TemporalGlobal precedent precedes Korea
LinkageNo recorded linkage

Matched concepts: software safety classification ↔ 소프트웨어 안전 등급; lifecycle processes ↔ 생명주기 프로세스; risk management integration ↔ 위험관리 통합; configuration management ↔ 형상관리

Cross-lingual similarity 71/100 (multilingual e5 embedding) — a computed signal, not proof.

Similarity type: IEC 62304:2006 Medical Device Software Lifecycle → KS C IEC 62304 의료기기 소프트웨어 생명주기 | software safety classification → 소프트웨어 안전 등급

Caveat: semantic similarity only — this tier records a hypothesis, not proof of causal influence.

Matched Concepts

4 pairs

GlobalKorean Echo

software safety classification

↓→

소프트웨어 안전 등급

lifecycle processes

↓→

생명주기 프로세스

risk management integration

↓→

위험관리 통합

configuration management

↓→

형상관리

Agenda Arc

Curated

Global purpose, Korean purpose, and precursor stages. Reasoning echo is discourse observation — not proof of coordination.

Global purpose

IEC 62304:2006 provides a framework of lifecycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.

Korean purpose

국가기술표준원은 IEC 62304:2006을 KS C IEC 62304로 채택하여 의료기기 소프트웨어의 생명주기 프로세스에 관한 국내 표준으로 삼고 있다. 식약처는 의료기기 허가·심사 시 KS C IEC 62304 준수를 요구하며, 이는 IMDRF 사이버보안 가이드라인과도 연계된다.

국가기술표준원 KS 표준 — 국가기술표준원은 IEC 62304:2006을 KS C IEC 62304로 채택하여 의료기기 소프트웨어의 생명주기 프로세스에 관한 국내 표준으로 삼고 있다. 식약처는 의료기기 허가·심사 시 KS C IEC 62304 준수를 요구하며, 이는 IMDRF 사이버보안 가이드라인과도 연계된다.

Reasoning echo

Observed framing link: IEC 62304:2006 Medical Device Software Lifecycle → KS C IEC 62304 의료기기 소프트웨어 생명주기 | software safety classification → 소프트웨어 안전 등급. Not a claim of coordination.

Started where

IEC (International Electrotechnical Commission)

Started how

via policy learning

Soft lawGlobalIEC (International Electrotechnical Commission)
Global instrument
IEC 62304:2006 provides a framework of lifecycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.
Primary source
LegislationKorea국가기술표준원 (KATS) / 식품의약품안전처 (MFDS)
국가기술표준원 KS 표준
국가기술표준원은 IEC 62304:2006을 KS C IEC 62304로 채택하여 의료기기 소프트웨어의 생명주기 프로세스에 관한 국내 표준으로 삼고 있다.
Primary source

Original (Global)

IEC 62304 provides lifecycle processes^② for safe design and maintenance of medical device software.

Echo (Korea)

KS C IEC 62304는 IEC 62304를 국내 표준으로 채택하여 의료기기 소프트웨어^① 생명주기^② 기준으로 활용한다.

Echo Strength

sourceVerified

hasKoreanSource

hasGlobalSource

hasDate

keywordDiversity

agendaTags

Influence Mechanism

policy learning

Origin

IEC (International Electrotechnical Commission)

Timeline

2006-2015

IEC 62304:2006 Medical Device Software Lifecycle → KS C IEC 62304 의료기기 소프트웨어 생명주기 | software safety classification → 소프트웨어 안전 등급

Sources

🌍Global source archived

🇰🇷국가기술표준원 KS 표준 archived

Related Patterns

IEC 60601 Medical Electrical Equipment Safety → KS C IEC 60601 의료전기기기 안전

IECIMDRFMFDS

P(B|A) = 75%temporal

40%

ISO 13485:2016 Medical Device QMS → KS P ISO 13485:2017 의료기기 품질경영시스템

IMDRFMFDS

P(B|A) = 45%category

20%

IMDRF Medical Device Cybersecurity → 한국 의료기기 사이버보안

IMDRF

P(B|A) = 41%category

16%

IMDRF Digital Medical Device & SaMD Harmonization

IMDRF

P(B|A) = 40%category

13%

IMDRF medical device regulation → 의료기기법 IMDRF 분류체계 채택

IMDRF

P(B|A) = 40%category

13%

IMDRF MDSAP → 한국 의료기기 GMP 국제조화

IMDRF

P(B|A) = 40%category

13%

IMDRF Unique Device Identification → 한국 의료기기 UDI 제도

IMDRF

13%

Digital Medical Products Act & IMDRF

IMDRF

P(B|A) = 38%agenda

10%

Semantically Related

Closest patterns by multilingual embedding (e5) — conceptual similarity beyond shared keywords. A computed signal, not a sourced claim.

IEC 60601 Medical Electrical Equipment Safety → KS C IEC 60601 의료전기기기 안전

Health & Bio

cos 0.90

ISO 13485:2016 Medical Device QMS → KS P ISO 13485:2017 의료기기 품질경영시스템

Health & Bio

cos 0.89

Digital Medical Products Act & IMDRF

Health & Bio

cos 0.88

IMDRF Digital Medical Device & SaMD Harmonization

Health & Bio

cos 0.88

IMDRF Medical Device Cybersecurity → 한국 의료기기 사이버보안

Health & Bio

cos 0.87

IMDRF Unique Device Identification → 한국 의료기기 UDI 제도

Trade & Supply Chain

cos 0.87

Keywords

IEC 62304medical device softwarelifecycleKS C IEC 62304의료기기 소프트웨어생명주기

Score Guide

Confidence — Editorial A–D tier from semantic, temporal, and linkage evidence.

Echo Strength — Metadata completeness score. Rewards verified sources, paired links, explicit dates, keyword diversity, and origin tags.

Vocabulary Overlap — Heuristic score measuring shared tokens between global and Korean texts. Reflects loanwords and repeated terms, not meaning across languages.